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Find your job with Sintetica SA

Apprendista laboratorista in biologia (afc) con opzione maturità professionale

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Quality Control

Fondata nel 1921 e con sede a Mendrisio, in Svizzera, il nostro obiettivo è quello di sforzarci continuamente nel migliorare le terapie, perfezionando il modo in cui esse sono formulate e utilizzate, a beneficio di medici e pazienti. Lo facciamo in stretta collaborazione con gli esperti clinici, con cui identifichiamo i bisogni attuali. Con questa fiducia e intuizione, spingiamo i limiti della scienza e della tecnologia per rendere le terapie più sicure, più facili da usare e migliori per i pazienti.  Per rafforzare il team di Controllo Qualità siamo alla ricerca di un/una Apprendista Laboratorista in biologia.   Principali mansioni - Campionamento ed analisi delle acque di processo - Monitoraggi ambientali microbiologici e particellari - Bioburden di soluzioni - Controlli microbiologici e chimico-fisici su semilavorati e prodotti finiti - Manutenzione degli strumenti di laboratorio - Registrazione dei controlli effettuati, redazione rapporti - Partecipazione alle occasioni formative aziendali per l'aggiornamento in materia di GMP   Requisiti Il conseguimento della maturità professionale tecnica integrata è obbligatorio - Assolvimento della scolarità obbligatoria (licenza media conseguita o in corso di ottenimento) - Interesse per le materie scientifiche e per le scienze - Attitudine al lavoro in team - Accuratezza e precisione - Senso del dovere e del rispetto - Spirito metodico e senso di osservazione   OffriamoContratto di tirocinio come da disposizioni dell'Ordinanza SEFRI sulla formazione professionale di base Laboratorista in biologia con attestato federale di capacità (AFC).Possibilità di apprendimento e perfezionamento professionale.Sintetica in quanto datore di lavoro promuove la diversità e l'uguaglianza di genere

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18/01/2022

Portfolio strategy & market access manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Sales Management / Sales

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Strategic Marketing Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Portfolio Strategy & Market Access Manager (fulltime position).   Position summary We are currently looking for a highly motivated person to support the Portfolio and Market Access Strategy with quantitative and qualitative analyses.   Essential tasks and responsibilities - Perform quantitative and qualitative analyses for new product opportunities including In-Licensing in collaboration with other Executives - Develop and implement market access strategy, including strategic imperatives and priorities at a global level, especially for key markets such as US and EU - Distillation of both scientific and commercial research of new product opportunities into sound recommendations, forecasts, sensitivities and business cases that are required for internal approval - Liaise directly with regional marketing directors to collect, validate and challenge ongoing new product opportunities - Responsibility for an optimal and timely Market access and Pricing of new and already launched products - Monitor the current and evolving requirements, emerging healthcare trends and provide strategic input for business development - Identification of new product opportunities using appropriate market intelligence databases and quantitative analyses - Provide high-quality presentations and documentation for senior management - Collaborate cross-functionally to engage on upstream innovation initiatives and pipeline prioritization to support the strategy definition and cross-functional alignment - Continuous monitoring of market development and proactive input on necessary adjustments of the Market access strategy - Manage the design and implementation of Health economic / Market access projects to generate the necessary data for an optimal reimbursement and lifecycle management for assigned products - Partnering with various external stakeholders to create a strong awareness of the value of our products and ensure optimal patient access - Assist in acquiring, managing, and developing new data assets to support portfolio decision-making, and develop new and innovative analyses through the integration of various data sources   Required skills and core competences - Bachelor's degree in Life Sciences and/or Health Economics. Further qualifications and courses in Market Access and Pricing will be considered an asset - 5+ years' experience within a market access & portfolio related position within the pharmaceutical industry or in Corporate Strategy - Deep knowledge of the Pharma industry and of the Health Care Environment - Expertise in working with and analyzing various pharmaceutical databases preferred, e.g., IMS/IQVIA - Excellent verbal and written communication skills in English. - Analytical thinker with excellent problem-solving skills with the ability to adapt to changing priorities and deadlines. - Excellent planning, organization and time management skills including the ability to prioritize and complete multiple projects. - Skilled in negotiations and collaborations with various functional units and commercial Directors to achieve the desired business results. - Able to work independently and as part of a team in order to complete assigned tasks within established deadlines.   We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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03/01/2022

Pharmacovigilance project manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Project / Program Management

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Pharmacovigilance Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmacovigilance Project Manager (fulltime position).   Position summary Under the supervision of the Drug Safety Manager, the Pharmacovigilance Project Manager will provide general support for the maintenance and continuous improvement of the Pharmacovigilance (PV) System. He/she is responsible for leading and managing our global/regional partners and PV service provider/s. He/she will ensure compliance with company procedures, national and international regulations/standards/guidelines for PV.   Essential tasks and responsibilities - Acting as the primary contact point for Global/regional project-related matters. - Oversight maintenance of clients and vendor/s; monitoring the current status and results of delegated activities also through the implementation of dedicated KPIs. - Guarantees the participation in strategic activities performed by external providers (e.g. audit, selection of local providers in EU and extra EU, etc) in order to implement a documented method to assure oversight of the PV service providers. - Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and local PV documents. - Project activities planning. - Drafting of company PV agreements with partners; maintenance of Company's agreement archive to guarantee adherence to the contracts and to PV obligations. - Conduct reconciliation activities with partners according to information sources and agreement in place. - Maintenance of adverse event reporting in all countries. Responsible for making decisions regarding adverse event reporting within the local guidelines in collaboration with local responsible persons. - Provide oversight of the receipt and processing of all adverse event reports/ expedited safety reports coming either spontaneously from any source or from a clinical trial for assigned projects. This might include, but is not limited to, executing routine quality review of AE reports, ensuring that case processing and data quality meet global regulatory compliance needs. - Supports development, implementation and ensures compliance of PV procedures such as SOPs, Work Instructions (WIs) and guidelines, escalating any deviation from procedure when required. - Provide support to the team activities for case processing and maintenance of Global Safety database. - Knowledge of Eudravigilance database and related tools for submission and signal detection. - Contribute to the development and maintenance of the company's main documents: Pharmacovigilance Site Master File (PSMF), Risk Management Plan (RMP), signal detection reports, aggregate reports (PSURs, DSURs etc.).   Required skills and core competences - Degree in health sciences discipline (e.g. pharmacist, Pharmaceutical Science or related disciplines). - At least 6 years' pharmacovigilance experience. - Deep knowledge of pharmacovigilance legislation and regulations (CH/EU/GCC/LATAM). - Work experience in a pharmaceutical company. - Fluent in written and spoken English. - Experience with the use of safety databases and Eudravigilance tools. - Preferably regulatory knowledge. - Organizational skills and PV project management skills. - Strong communication skills. - Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules. - Ability to prioritize and to be flexible and receptive in changing process demands. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.

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03/01/2022

Pharmaceutical development project manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Pharmaceutical Development Department at our HQ in Mendrisio, we are looking for a Pharmaceutical Development Project Manager (full-time position).   Position summary The Pharmaceutical Development Project Manager will manage projects related to:   - New biopharmaceutical products. - Optimization of processes, presentations and formulations related to products already in place.   The candidate will operate under the direct coordination of the Pharmaceutical Innovation Manager in collaboration with the Pharmaceutical Development Team and the Scientific Affairs Department to which the Pharmaceutical Development Team belongs. The candidate will follow the projects starting from the 'idea' until the final results as required by the CMC part (Module 3 and 2.3) of the related eCTD.   Essential tasks and responsibilities - Participation in the design of new projects, screening activities (bibliographic research, competitor research, intellectual property), risk/benefit assessment, gap analysis and budget/timelines evaluation. - Coordination and support of the internal and external activities related to the assigned projects. - Collaboration with internal departments (R&D Lab, Clinic, QA, QC, Supply Chain, Production, Industrialization) to reach the project goals. - Drafting the necessary documentation for the correct management of the projects, including protocols and final development reports. - Participation in the activities related to the intellectual property of new or existing projects (evaluation of new patent opportunities, preparation and submission of new patents, collaboration with patent attorneys/consultants). - Travel (10-20% of total time) to supervise R&D and production activities performed in other Sintetica sites and with external partners. - Improve pharmaceutical development and biopharmaceutical innovation know-how by attending courses, seminars and meetings. - Perform other duties as required.   Required skills and core competences - Bachelor's degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry, Industrial Pharmacy). - 10 years of post-degree work experience, 5 years in research and development project management. - Knowledge of ICH/EU/US/Swiss guidelines related to the technical subjects of manufacturing equipment and process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation. - Experience in project management tools such as MS Project and Smartsheet. - Good experience in the use of MS software. - Proven track record with project management processes including change control, risk management and conflict resolution. - Able to work effectively within cross-functional teams inside and outside the organization. - Experience in the development of biologics and advanced therapies would be an asset.  - Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management would be an asset. - Very good English communication and writing skills. The knowledge of French would be an asset. - Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules. - Analytical thinker with strong problem-solving skills - Strong communication skills, both oral and written. - Commitment to continuous improvement.   We offer Full-time employment in an international, young and dynamic work environment. Sintetica promotes Diversity and Gender Equality.

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03/01/2022

Regulatory affairs development manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Regulatory Affairs Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Regulatory Affairs Development Manager (fulltime position).     Position summary Sintetica is facing a huge transformation which impacts its structure, strategies, culture, policies, and technology. The new Company policy will bring to embrace new business opportunities that go beyond anesthetic and analgesic therapeutic area. New policy of product acquisition, aimed to widen the Company portfolio, implies the creation of a Task force engaged in due diligence to evaluate regulatory risks and opportunities in the concerned worldwide markets. This new direction together with the increasing number of registration applications triggers for a re-design of the Regulatory Affairs department to bring in highly experienced people with new competencies and talents to manage increased complexity of projects and to deliver successful results, contributing effectively to the Company growth. The candidate will report directly to the Corporate Regulatory Affairs Manager and supervise and mentor the Regulatory Team. He/She will also collaborate with the various internal functions external stakeholders (CMOs, commercial partners, etc.).     Essential tasks and responsibilities With the support of the Regulatory Affairs Team and with the aim of promoting the team members' individual growth, the responsibilities include: - Establishing a strategy from development to registration and supporting the execution (directly and/or through supervising the operational resources) of the global regulatory affairs lifecycle and manage approved registrations through collaborating with the various internal and external stakeholders (CMOs, commercial partners, etc.). - Overseeing development projects and performing Due Diligence activities to evaluate regulatory risks and opportunities. - Identifying in advance potential hurdles that might impact the regulatory success of development activities and/or potential licensing in processes. - Supporting the Regulatory Corporate Manager in IND, NDA, and ANDA strategy preparation, involving and training the RA Team members responsible for operational activities. - Providing operational support with strategic regulatory documents to help drive timely deliverables. - Coordinating and driving team meetings to ensure quality and timely responses to health authority queries. - Securing global submission plans together with the main area Project Manager and ensuring these plans can be executed on time. - Supervising the marketing application submission team (EU/CH/US and RoW), helping to develop strategy and content for global dossiers. - Translating regulatory requirements into practical workable submission plans. - Supervising the resources currently managing patents and trademarks by navigating the relevant multiple legal domains in pharmaceutical research, development, and innovation. - Remaining constantly updated on pharmaceutical regulations and sharing knowledge within the RA team members to promote their growth.     Required skills and core competences[] - Solid scientific background (BSc, MSc, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine). - At least 15 years' experience in regulatory affairs preferably in global/HQ positions and/or across different geographic locations. - Deep knowledge of drug development processes, European regulations, FDA regulations and procedures. - Consolidated Experience in performing due diligence activities in early and late-stage product development (EU/US, mainly) and in pre-submission meetings with HAs (FDA, EMA and EU HAs) to define regulatory strategy for NDA, centralised, and decentralised procedures. - Previous experience in intellectual property protection regulatory management in the pharmaceutical industry and in development and submission strategies for emerging countries (e.g., China, India, Russia, Brazil…) would be a plus. - Excellent level of written and spoken English. - Strong leadership skills, including the ability to set goals, provide constructive feedback, build positive relationships, and improve business results. - Indirect or direct people management experience. - Autonomous, efficient, proficient in project management, precise and detail oriented. Able to handle multiple projects with good prioritization skills. - Confident in using Project, Excel, and Power Point to present project planning and Gantt charts.     We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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03/01/2022

Junior system engineer

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Technology / IT

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Digital Affair Department at our HQ in Mendrisio we are looking for a Junior System Engineer.   Position summary The candidate will be part of the ICT team and will report to the Corporate IT Infrastructure Manager. The role involves a number of initiatives that the company is addressing as part of a wide-ranging Digital Transformation programme. - Support the Helpdesk activities concerning: - Installation, configuration and technical support for desktop/laptop devices. - Installation, configuration and technical support for mobile devices/company printers - Configuration and technical support concerning enterprise applications - Provision, installation and configuration of user devices (desktop, laptop, mobile). - Collaboration with the ICT team or other vendor partners to ensure the proper functioning of the company's infrastructure and its evolution in line with the company's strategy and the guidelines defined by the Department Director. - Support and collaboration on the following activities: - Management of the virtualized on-premise (VMware) and on-cloud server infrastructure - Management of network, telephone and other peripheral equipment. - Collaboration management (MS 365) - Coordination of the development of business applications to support some business processes   Requirements - Degree/diploma in computer science, computer engineering or electronics or equivalent disciplines - 1/2 years' experience in the role will be considered an asset - Knowledge of VMware environment, MS stack (Active Directory, MS SQL Server, Windows Server) and MS 365 Collaboration Suite - Knowledge of Networking and Cybersecurity - Knowledge of ITSM environments (Eeasyvista or similar) - Knowledge of SAP systems concerning infrastructure management (SAP Basis) - Not mandatory - Strong propensity for team working and a strong orientation towards objectives and problem solving - Flexibility, autonomy, proactivity, innovation-oriented - Good knowledge of the English language - Knowledge of the above processes and solutions in the pharmaceutical industry would be an advantage.   We offer Full-time employment in a young and dynamic work environment Sintetica promotes Diversity and Gender Equality.

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03/01/2022

Controller

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Accounting / Banking / Finance

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Finance Department at our HQ in Mendrisio we are looking for a Controller.   Position summary The candidate will be part of the Finance & Administration Department and will report directly to the Corporate Finance Controller.   Essential tasks and responsibilitiesAs a member of the Finance Department the candidate will oversee the following activities: - Management Control and monthly Group Reporting Packages setup - Development Modelling Platform and What-If Scenarios - Operations Budgeting - Master Budget and subsequent Forecasts - Monitoring the correct implementation of business plans and development of periodic reports - KPI Corporate Profitability Monitoring - Cost and Variance Analysis - Assist in the formulation of internal controls and policies to comply with legislation and established best practices - Assist in the preparation of financial statements in compliance with official guidelines and requirements - Participate in preparation for the annual audit   Requirements - Degree/diploma in accounting, finance, business administration or equivalent disciplines - 4-6 years' experience in the role - Solid knowledge of GAAP (Generally Accepted Accounting Principles) and regulation - Excellent knowledge of accounting and financial processes (budgeting, financial closure, reporting etc.) - Understanding of data analysis and forecasting - MS Office, especially excel and accounting software proficiency (SAP) - Well-organized with ability to prioritize - Team-working oriented approach - Very good communication and interpersonal skills - Attention to detail and problem-solving ability - Flexibility, autonomy, proactivity, innovation-oriented - Ability to learn fast in a dynamic environment combined with data accuracy and fast reaction in case of an ad hoc analysis - Good knowledge of the English language - Knowledge of the above processes and solutions in the pharmaceutical industry would be a plus.   We offer Full-time employment in an international, young and dynamic work environment Wide view of all aspect of the business and its connections with all the corporate functions Possibility to growth your overall knowledge Sintetica promotes Diversity and Gender Equality.

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03/01/2022

Bio-pharmaceutical development project manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Pharma R&D Department at our HQ in Mendrisio, we are looking for a Bio-Pharmaceutical Development Project Manager (fulltime position).   Position summary The Bio-Pharmaceutical Development Project Manager will manage projects related to: - New bio-pharmaceutical products. - Optimization of processes, presentations and formulations related to products (liquid formulations) already in place. The candidate will operate under the direct coordination of the Pharmaceutical Innovation Manager and in collaboration with the Pharmaceutical Development Team and in the Scientific Affairs Department to which the Pharmaceutical Development Team belongs. The candidate will follow the projects starting from the 'idea' until the final results as required by the CMC part (Module 3 and 2.3) of the related eCTD.   Essential tasks and responsibilities - Participation in the design of new projects, carrying out screening activities (bibliographic research, competitor research, intellectual property), risk/benefit assessment, gap analysis and budget/timelines evaluation. - Definitiom of functional specifications of both formulation and final product, considering the user requirement specifications identified in the design phase. - Coordination and support of the internal and external activities related to the assigned projects. - Collaboration with internal departments (R&D Lab, CMC, Clinic, QA, QC, Supply Chain, Production, Industrialization) to reach the project goals. - Drafting of the necessary documentation for the correct management of the projects, including protocols and final development reports. - Participation in the activities related to the intellectual property of new or existing projects (evaluation of new patent opportunities, preparation and submission of new patents, collaboration with patent attorneys/consultants). - Travel (10-20% of total time) to supervise R&D and production activities performed in other Sintetica sites and with external partners. - Improve pharmaceutical development and biopharmaceutical innovation knowhow by attending courses, seminars and meetings. - Perform other duties as directed.   Required skills and core competences - Bachelor's degree in a scientific discipline (Pharmacy, Industrial Pharmacy, Biotechnology) - 8 years of post-degree work experience, 3 years in research and development project management. - Experience in manufacturing and development of sterile liquid products. - Experience in biologics and/or biodegradable nanoparticles development. - Knowledge of ICH/EU/US/Swiss guidelines related to the technical subjects of manufacturing equipment and process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation. - Experience in project management tools such as MS Project and Smartsheet. - Good experience in the use of MS software. - Proven track record with project management processes including change control, risk management and conflict resolution. - Able to work effectively within cross-functional teams inside and outside the organization. - Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management would be an asset. - Very good English communication and writing skills. The knowledge of French would be an asset. - Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules. - Analytical thinker with strong problem-solving skills. - Ability to resolve conflicts and develop a course of action leading to beneficial outcomes. - Strong communication skills, both oral and written. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.  

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03/01/2022

Quality assurance manager

Sintetica SA
Switzerland, Neuchâtel, Val-de-Travers - Sintetica SA
Pharmaceutical
Middle and Top Management

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Quality Assurance Team in Couvet, we are currently looking for the Quality Assurance Manager Couvet (Canton de Neuchâtel, CH)   Position summary Within the Corporate Compliance & Innovative Projects Unit, reporting hierarchically to the site Director and functionally to the QA Corporate Director, the Quality Assurance Manager is responsible for the Company's Quality System ensuring the ongoing reliability of the entire manufacturing process as well as the quality of the final product on site. The QA Manager ensures the proper application of the GMP, the correct execution of all certifications with the accredited bodies, and the overall alignment to the Corporate Quality procedures.   Key tasks and responsibilities The QA Manager (he/she) will be responsible for -  Measuring and improving the QA performance according to the relevant KPIs -  Managing and overseeing all QA activities including validations, qualifications, Execution of batch record review, validation, qualification of equipment utilities and machines, Deviation, complaints and Change Control management, Supplier qualification for finished and semi-finished products, materials, raw materials and their periodic requalification …etc.   The incumbent will be responsible and focused on -  Leading and developing the existing QA Team of 10 resources -  Implementing the policy of Quality Assurance according to Corporate QA guidelines -  Defining SOPs (Standard Operating Procedures) and GMP-related documentation along with other involved units/ department Managers and secure compliance with GMP -  Analysis and evaluation of monitoring data and key performances indexes in order to insure a continuous improvement of the quality system -  Quality investigations and definition of corrective and preventive actions -  Issuance of Master Batch Records, validation and qualification protocols, reports and GMP related documents (risk analysis, technical reports, etc.) - Managing self-inspection and third parties' inspections - Assuring that all QA Activities are performed in time and in accordance to finished product release processes  - Carrying on controls and audits of the internal Quality system   Required qualification and experience   -  Master/Doctor's degree in Pharmacy, in Chemistry, Engineering, or related technical science disciplines -  Over 10 ? 15 years' experience - with successful team management - within the pharmaceutical industry, in QA or Production, preferably gained in small-medium Pharmaceuticals with marketing authorization (GMP certificated) released by local Health authorities (FDA, Swissmedic,…) -  Expertise in injectable aseptically filled products (manufacturing) and terminally sterilized products will be a must, together with excellent knowledge and expertise in pharmaceutical GMP procedures -  Digital thinker, the QAM will contribute to and promote Sintetica' innovation and digitalization process   Skills -  Excellent knowledge of French and English, verbal and written. Italian would be an asset -  Strong management and leadership skills to lead and motivate the team -  Organizational capabilities -  Excellent relational and communication skills, keen to collaborate proactively -  Pragmatic and with a problem-solving attitude -  Strong commitment to continuous improvement We look for someone with Swiss work permit or willing to relocate.   We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Couvet is located in the beautiful nature of the Val-de-Travers, Canton of Neuchatel, Switzerland. Sintetica promotes Diversity and Gender Equality.

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20/12/2021

Qc lab technicien/ne chimie (stabilité)

Sintetica SA
Switzerland, Neuchâtel, Val-de-Travers - Sintetica SA
Pharmaceutical
Quality Control

Founded in 1921 and headquartered in Mendrisio, Switzerland, our goal is to continuously strive to improve therapies, enhancing how they are formulated and used, for the benefit of clinicians and patients. We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer, easier to use, and better for patients. In 2020 we reliably supplied millions of doses of improved therapies across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address unmet needs. To strengthen our Quality Assurance Team in Couvet, our second production site, we are currently looking for                                                                                                                                        QC Lab Technicien/ne Chimie (Stabilité) Site de Couvet (Canton de Neuchâtel, CH)   Mission   Le QC Lab Technicien chimie joue un rôle essentiel dans le déroulement des opérations quotidiennes du laboratoire de chimie. Il assure l'exécution des essais et analyses de eaux, des matériaux, des matières premières, des produits semi-finis/finis et des échantillons de stabilités selon les procédures.   Responsabilités principales   ?Assurer l'exactitude des analyses de stabilités, des protocoles et des spécifications de stabilités dans les délais d'analyse selon les priorités (Organisation et planification) ? Rédiger les documents du contrôle qualité (SOPs, Protocoles, rapports, …) ? Compiler les dossiers d'analyses ? Conduire des analyses par LC & GC, UV-Vis e IR ? Connaissance à traiter les investigations OOS et OOT et conduire la rédaction des rapports ? Assurer tous les aspects du laboratoire, y compris sans se limiter : les instruments / équipements et les fournitures nécessaires pour assurer le bon fonctionnement du laboratoire chimie   Formation et compétences requises   ? Diplôme académique en chimie analytique ? 3 -5 années d'expériences dans un poste similaire ou dans un laboratoire de Contrôle Qualité ? Excellente connaissance des exigences GMPs et réglementaires propres au laboratoire ainsi que de la documentation GxP ? La connaissance du secteur pharmaceutique ? Maitrise du pack MS Office, et des logiciels Chromeleon, Parcel et LEMS sera un plus ? Excellente connaissance du français (parlé et écrit) et une bonne connaissance de l'anglais sont obligatoires ? Sens critique ? Rigueur, fort esprit d'analyse ? Solides compétences relationnelles et de communication ? Capacité à travailler en équipe et de façon autonome dans un environnement très dynamique   Nos candidat-e-s ont déjà un permis de travail suisse ou sont prêts à s'installer en Suisse. Nous offrons Un emploi permanent dans un environnement de travail très dynamique, jeune et avec une culture d'entreprise positive. Le village de Couvet est immergé dans la nature et situé dans la région de la Val-de- Travers, dans le Canton de Neuchâtel (CH). Sintetica promeut la diversité et l'égalité de genres.

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20/12/2021
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