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Find your job with Sintetica SA

Business analyst

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Marketing / PR

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Global Markets Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Business Analyst (fulltime position).   Position summary The Business analyst (BA) help guiding businesses in improving processes, products, services, and software through data analysis. The BA collect and stores data on sales numbers, market research, or other behaviors, bringing technical expertise to ensure the quality and accuracy of that data, then process, design and present it in ways to help people, businesses, and organizations make better decisions. As a member of the Strategic Marketing, you will work in a highly collaborative environment to communicate trends and align marketing, sales, operations, and service activities to manage and nurture the company's engagement with partners. The Business analyst directly report to the Strategic Marketing Corporate Manager   Essential tasks and responsibilities - Identify problems within a business, including through using data modelling techniques. - Communicate with senior people in organizations to find out what they hope to achieve. - Formulate ways for businesses to improve, based on previous research. - Persuade internal and external stakeholders of the benefits of new technology or strategies. - Creating a detailed business analysis, outlining problems, opportunities, and solutions for a business. - Identify market intelligence on competitive activity, communicate to appropriate internal resources in a timely manner; develop and implement sales plans to meet business goals. - Continuous collaboration with International Product Managers.   Required skills and core competences - Bachelor/master's degree in a business-, computing-, economics-, or numeracy-related subject. - 3-5 years' minimum experience in Consulting and/or Business analysis in the pharma sector. - Commercial awareness and Knowledge of the business structure. - Problem-solving and analytical skills. - An interest in, and understanding of, project management techniques and computing system. - Excellent written and verbal English communication skills. - Strong relational, communication and adaptability skills. Open to new ideas and approaches. Global Culture. - 360° commitment to develop expertise on activities requiring high flexibility. Commitment to continuous improvement. - Skilled in negotiation and collaborating with various functional units to achieve 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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New!
05/03/2021

International product manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Marketing / PR

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Global Markets Department at our headquarter in Mendrisio (Switzerland), we are currently looking for an International Product Manager (fulltime position)   Position summary The International Product Manager (IPM) will specialize in one of Sintetica's main area of business (Neuromodulation, Innovative Anesthesia, Pain Management and Intensive Care) and will conduct thorough qualitative and quantitative research to identify new market opportunities and customer preferences/patient need. International Product Manager are friendly, well-spoken and ready to close the deal. The IPM directly report to the Corporate Strategic Marketing Manager   Essential tasks and responsibilities - Set specific marketing goals that align with the overall direction and business goals. - Deep focus on scientific activities. - Deep focus and understanding of competitors. - Understanding of current product portfolio and new opportunities in cooperation with Scientific Affairs Direction. - Scouting for new potential partners matching with Sintetica's values and Business Strategy in cooperation with Sales Divisions. - Scouting for new KOLs in cooperation with Scientific Affairs Direction. - Sharing best practices among the BTC/BTB. - Guiding Sales Divisions on priorities of products and markets after the agreement with Scientific Affairs and Industrial Affairs based on business cases. - Translate product strategy into user stories. - Prioritize user stories based on the product strategy.   Required skills and core competences - Bachelor/master's degree in scientific discipline. - 5 years' minimum experience in an International/Multinational Pharma Enterprise is required. - Experience in sales and marketing not mandatory but strongly recommended. - Business acumen. - Excellent written and verbal English and Italian communication skills. - Proficient in one other language preferred (Spanish, German and/or French). - Strong relational, communication and adaptability skills. Open to new ideas and approaches. - 360° commitment to develop expertise on activities requiring high flexibility. - Skilled in negotiation and collaborating with various functional units and commercial Directors to achieve desired business results. - Able to work independently and as part of a team in order to complete assigned tasks within established deadlines. - Commitment to continuous improvement and a Global Culture.   We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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New!
05/03/2021

Pharmaceutical innovation manager

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Pharmaceutical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmaceutical Innovation Manager (fulltime position).   Position summary                                     Sintetica is undergoing a profound transformation that involves strategic and organizational process areas as well as the equally important structural aspects. The review of our business strategies involves the expansion of our product portfolio and license-in opportunities for drugs with clinical and formulation characteristics which are different from the ones already present in Sintetica. This will offer an interesting opportunity to broaden our know-how for both products and processes. Along with it, a strategy is undergoing for the creation of new production lines and for the renewal of existing ones, to support the growing needs and to follow process and product innovation. The management of this multidirectional growth requires an expansion of the scope of action and consequently of the organizational structure of Pharmaceutical Development Department. A new managerial profile is therefore required to direct the development of our know-how towards product innovation and to identify new areas of growth. His/her task will be to research and to implement product innovation opportunities considering all aspects of the product, starting from formulation and analysis, and including aspects such as packaging, process, methods of use / application / presentation to the final user.   Essential tasks and responsibilities The Pharmaceutical Innovation Manager, in collaboration with the Non Clinical & Clinical Development Department, Regulatory Affairs Department, Industrial Affairs Department and Marketing Teams - Will collaborate on new proposals for the implementation of our product portfolio by monitoring the relevant scientific literature, patent searches, screening of newsletters from the main regulatory bodies. - Will evaluate licence-in products to promptly define the feasibility and necessary resources and will take part, for each product to be developed, to appropriate kick-off meetings in order to evaluate every aspect of development and anticipate any complexities. - Will prepare what is necessary for license-out activities in order to present the products developed internally to potential customers, he will also transfer the product development to third parties or involve other partners in internal developments. - Will evaluate opportunities for patent coverage of products under development. - Will develop and apply product and process innovation. - Will avail himself of the support of the Project Management group of which he will be responsible for supervision and coordination and of which he will have to direct the growth towards the concept of 'integral product innovation' and towards the identification of new development areas. - Will answer directly to the Pharmaceutical Development Corporate Manager and will work with him on the redefinition of the Project Management operational methods and will support him in designing the evolutionary line of Pharmaceutical Development, also in relation to the growth of other functions in the company, with a mid/long-term perspective. - On an annual basis (by the end of September), she/he will contribute to setting up the investment request plan for the following year, in relation to his competence area.   Education, experiences and required soft skills - Bachelor's degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry) - 10 years of post-degree work experience - Previous experience in the pharmaceutical industry. - Very good English communication and writing skills. The knowledge of French will be considered an asset. - Proactivity, autonomy, precision, good teamwork skills, excellent planning and stress management skills and ability to cope with tight schedules. - Able to work efficiently within a cross-functional team. - Analytical and problem-solving attitude. - Great communication skills, both oral and written. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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23/02/2021

Industrial automation engineer

Sintetica SA
Switzerland, Neuchâtel, Val-de-Travers - Sintetica SA
Pharmaceutical
Engineering

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anaesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production, and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes collaboration, creativity and informed risk-taking in an exciting and comfortable work environment. Sintetica has two production sites, in Mendrisio and in Couvet. To strengthen our Industrial Automation and Innovation Team within our production department in Couvet (Canton of Neuchatel, Switzerland), we are looking for a talented Industrial Automation Engineer Couvet site (Canton of Neuchâtel, CH)   Mission and Position summary The Team of Automation and Industrial Innovation is fully engaged in bringing Sintetica to a complete digitalisation of all industrial processes, with focus on the production lines and on the management of Quality Control laboratories and R&D departments. The Production team is pursuing the objective of continuous improvement and implementation of new automated production lines to support company growth and pursue process and product innovations. The Automation Engineer (he/she), reporting locally to the Director of Production functionally and hierarchically to the Industrial and Innovation Corporate Manager, will ensure improvement, implementation and maintenance of production machines and vision systems in collaboration with the Maintenance and Engineering Teams on site and with the Automation, under the guidance of the Innovation Team in Mendrisio, at the Head Quarter. Key tasks and responsibilities Automation - Troubleshooting and debugging of production machines (primary and secondary packaging) - Suggest and improve efficiency of the production machines/production lines (e.g. add waste count, add new function, additional control, etc.). - Analysis and improvement of machine cycle times. - Training of technical staff - Drafting of procedures - Work with suppliers (from definition of the offer to the commissioning of equipments) Vision system - Programming and troubleshooting of SEA Vision systems (OCV/serialization). - Improve optical controls (e.g., repositioning/adding new cameras). Industrial innovation - Direct involvement in on-site industrial innovation strategic projects. In particular, - Renovation/construction of new highly automated production lines and digitalization of production lines and laboratories (MES, LIMS).   Education and Skills required - Master's degree, preferably in Automation, Electronics, Mechanics or Computer Science - Minimum experience of 3-5 successful years on a similar function in the industry: experience in the pharmaceutical industry [appreciated.] - Mastery of SEA Vision Systems (OCV/serialization) - Mastery of production machines with PLC (primary and secondary packaging) - Knowledge of Supervisory Systems (SCADA) - Knowledge/designing of electrical wiring diagrams. - Good relationship and communication skills to collaborate with and among teams. - Ability to negotiate with suppliers/customers. - Multidisciplinary technical know-how (high-tech, computer programming, mechanics, electronics, electrical engineering, enslavement, robotics...). - Project management with a sense of organization and rigor. - Ability to tackle and solve problems. - Good knowledge of technical English. Knowledge of French very appreciated, Italian is a plus. In addition: - Curious, proactive, open, flexible. - Digitally oriented and innovation thinking. - Autonomous, with strong collaborative spirit. - A sense of responsibility is also an essential asset that will enable the missions entrusted to be carried out. We offer : Fulltime permanent employment in a young, dynamic work environment and positive culture. Couvet village is located in the beautiful nature of the Val-de-Travers, in the Canton of Neuchâtel, Switzerland. Sintetica promotes Diversity and Gender Equality.  

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21/02/2021

Cmc specialist

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Pharmaceutical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a CMC Specialist (fulltime position).   Position summary The CMC Specialist will manage projects related to both: - Preparation of new finished products dossier. - Quality change dossiers to be approved. He/She will operate under the direct coordination of the CMC Strategy Manager and in collaboration with the Pharmaceutical Development Team and the colleagues in the Scientific Affairs Department. He/She will follow the project starting from the input, which could be a new product dossier or a change implementation in an approved dossier, until the submission of the complete CMC part (Module 3 and 2.3) or specific sections.   Essential tasks and responsibilities - Collaborations with Regulatory Affairs and Technical Departments to define regulatory CMC strategies and identification of potential regulatory risks. - Identification of the required documentation for CMC submissions and negotiation with the Technical Departments of the approved technical data and documents delivery. - Review of post-approval CMC changes (Change Controls) and assessment of the regulatory impact on the affected dossiers in collaboration with Regulatory Affairs. Definition of the regulatory strategies for variation and preparation of the concerned CMC section. - Planning and preparation of CMC documentation for both new product registration and variation applications. - Collecting the responses to inquiries from Regulatory agencies on CMC content of regulatory submissions. - Preparation of meeting materials and attending to Health Authority advices related to CMC drug development activities and submissions.   Required skills and core competences - Bachelor's degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry) - 5 years of post-degree work experience - Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management. - Knowledge of EU/US/Swiss regulations related to the eCTD CMC Part (Module 3 and 2.3) - Knowledge of ICH/EU/US/Swiss guidelines related to technical subjects such as manufacturing equipment and process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation will be considered an asset. - Good experience in the use of MS software. - Very good English communication and writing skills. The knowledge of French will be considered an asset - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude, excellent planning skills, good stress management - Management and organizational skills, flexibility, learning agility and strategic thinking. - Ability to work effectively within a cross-functional team   - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.

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17/02/2021

Quality assurance specialist – validation

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anaesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production, and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. Within the Corporate Validation Unit, to strengthen our local Quality Assurance team, we are currently looking for a Quality Assurance Specialist ? Validation Site of Couvet (Canton de Neuchâtel CH)   Position summary The Validation Specialist will be integrated in the Quality Assurance Team in Couvet and will report to the Corporate Validation Specialist. He / She will contribute to establish and maintain the Company's Quality System and ensure the ongoing reliability of the manufacturing process. Focusing on Couvet QA processes, the Validation Specialist will be responsible for the proper qualification of the equipment and installations, and for the process validation.   Essential tasks and responsibilities - Editing and issuance of qualification documents as well as final reports and GMP related documents (risk analysis, technical reports, etc.) - Execution of qualification of equipment utilities and machines, validation processes and cleaning validation processes - Analysis and evaluation of monitoring data and KPI to ensure a continuous improvement of the quality system - Deviation management and Change Control - Quality investigations and definition of corrective and preventive actions - Definition of standard operating procedures (SOP) and GMP-related documentation along with other involved units/ department Managers - Contribution to the innovative implementation of industrial Projects - Involvement in self-inspections and in third parties' inspections More specifically in the role of Validation Specialist, he/she will: - Plan and coordinate validation activities in collaboration with the concerned department manager - Develop and maintain relationships with external validation service suppliers, planning their interventions - Based on the documentation, deliver Training to employees who are involved with validation activities - Participate to issue the Validation Master Plan and the Validation Projects Plans related to the industrial projects. - Accomplish planned validation tasks, with the support of external or internal staff. - Assure that the installation of new machines and utilities is performed according to adequate documentation (QD, IQ, QO, etc.).   Required skills and core competences - Bachelor/Master degree in technical science related subjects (Chemistry, Pharmacy, Engineering or equivalent) - 3-5 years' experience in the Pharmaceutical field, preferred experience in the execution of Validation and Quality Assurance activities - Expertise in injectables anesthetics (Production) and terminally sterilized products will be a plus with the - Good knowledge of the pharmaceutical industry and expertise in pharmaceutical manufacturing and GMP procedures will be considered an asset - Fluent in spoken and written French and English, knowledge of Italian will be considered an asset - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude. - Management and organizational skills, flexibility, learning agility and strategic thinking - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young, dynamic work environment and positive culture. Couvet is located in the beautiful nature of the Val-de-Travers, in the Canton of Neuchatel, Switzerland. Sintetica promotes Diversity and Gender Equality.  

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04/02/2021

Quality assurance specialist

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anaesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production, and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our local Quality Assurance team, we are currently looking for a Quality Assurance Specialist Site of Couvet (Canton de Neuchâtel CH)   Position summary The Quality Assurance Specialist supports our Site Quality Assurance Manager by establishing and maintaining the Company's entire Quality System.   Essential tasks and responsibilities - Deviation, complaints and Change Control management - Quality investigations and definition of corrective and preventive actions - Analysis and evaluation of monitoring data and key performances indexes in order to insure a continuous improvement of the quality system - Supplier qualification for finished and semi-finished products, materials, raw materials and their periodic requalification - Issuance of Master Batch Records, validation and qualification protocols, reports and GMP related documents (risk analysis, technical reports, etc.) - Definition of standard operating procedures and GMP-related documentation along with other involved units/ department Managers - Execution of batch record review, validation, qualification of equipment utilities and machines - Involvement in self-inspections and in third parties' inspections   Required skills and core competences - Bachelor/Master degree in technical science related subjects (Chemistry, Pharmacy, Engineering or equivalent) - Minimum 5 years' experience in the Pharmaceutical field, Production or Quality Assurance - Expertise in injectables anesthetics (Production) and terminally sterilized products will be considerd an asset - Good knowledge of the pharmaceutical industry with expertise in pharmaceutical manufacturing and GMP procedures will be considerd an asset - Fluent in written and spoken French and English - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude. - Management and organizational skills, flexibility, learning agility and strategic thinking. - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young, dynamic work environment and positive culture. Couvet is located in the beautiful nature of the Val-de-Travers, in the Canton of Neuchatel, Switzerland. Sintetica promotes Diversity and Gender Equality

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04/02/2021

Digital quality assurance specialist

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Quality Assurance Team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Digital Quality Assurance Specialist (fulltime position).   Position summary Digital Quality Assurance Specialist ensures the efficiency of the IT infrastructure which connects processes, people and tools in order to guarantee a timely delivery of the product value to consumers and provide for the company Knowledge Base We are looking for a Digital Quality Assurance Specialist to join our growing global Pharmaceutical company. Numerous ongoing and new digital projects, covering Supply Chain, Production, Quality Control, R&D, Quality Assurance, Marketing and distribution, have to be managed by a team where the Digital Quality Assurance Specialist will drive the change from a Quality Assurance perspective.   Essential tasks and responsibilities - Provide practical and strategic support to optimize the digital transformation of the company. - Understand the processes and technologies involved in digital projects. - Possess best practice skills gained from training as well as real-world experience. - Help to mitigate risks to ensure functional & non-functional requirements are addressed within each digital project. - Leverage the virtualization of data and processes. - Get involved in new projects in which he/she will give advice and set up the approach to QA for the project on his own or in cooperation with the QA team. More specifically: - Review requirements specifications and technical design documents to provide timely and meaningful feedback. - Create detailed, comprehensive, and well-structured test plans and test cases. - Estimate, prioritize, plan, and coordinate testing activities. - Work in a QA team to analyse quality requirements, report and guarantee the quality of the digital solutions. - Manage the testing environment. - Provide support to junior team members. - Lead and facilitate testing. - Provide updates to the task estimates and the status of your assigned tasks.   Required skills and core competences - Chemist, Pharmacist or Engineer - 3+ years of experience in QA of pharmaceutical companies. - Experience of web-based applications and digital solutions. - Experience with the creation/maintenance of test documentation. - Preferable knowledge of programming languages (HTML, CSS, and XML). - Clear understanding of the software development lifecycle, including quality assurance process. - Knowledge of software QA methodologies, processes, and tools. - Tracking and resolving issues after UAT, acceptance criteria. - Experience with evaluating test results and reporting. - Ability to deal with multiple projects. - Openminded and innovating approach. - Excellent spoken and written English.   We offer Fulltime permanent employment in a young work environment and positive culture. Sintetica as an employer promotes diversity and gender equality.

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04/02/2021

Clinical development specialist

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Clinical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Clinical Development Specialist (fulltime position).   Position summary   The Clinical Development Specialist will manage and support the clinical development of the global company portfolio (a mix of established products and innovative therapies), following all the phases of clinical projects, starting from the clinical trial design until the submission of the registration dossier. She/He will operate under the direct coordination of the Clinical Development Corporate Manager and in collaboration with the Clinical Development Team and the Scientific Affairs Department. She/He will be the projects' scientific reference point for all the relevant internal and external stakeholders.   Essential tasks and responsibilities   - Responsible for clinical research and development projects. - Coordination and support of the strategic activities related to the assigned project. - Provides scientific expertise to functional areas such as marketing, non-clinical development, pharmacovigilance and regulatory affairs in accordance with the company's strategy. - Overview of clinical study protocols and other critical documents. - Support to clinical operations and scientific supervision during clinical trials. - Preparation of scientific advices with EU and US authorities. - Medical writing: contribution to the preparation of pre-clinical and clinical (CTD modules 2, 4 and 5) sections for FDA and EMA dossiers, preparation of EU Pediatric Investigation Plans (PIP), US Pediatric Study Plan (PSP), Investigator Brochures, Briefing Documents, answers to objections, etc. - Support during European Authorities and FDA GCP inspections.   Required skills and core competences   - Master's Degree in health-related subjects (e.g., pharmacy, biotechnology, biology, or similar disciplines). - Previous experience in the pharmaceutical industry of 3-5 years. - Fluent in written and spoken English. - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude. - Management and organizational skills, flexibility, learning agility and strategic thinking. - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young work environment and positive culture. Sintetica promotes diversity and gender equality.  

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04/02/2021

Quality assurance specialist

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

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients all over the world through innovative solutions with excellence in development, production, and marketing. People are our most valuable asset therefore patients, as well as the quality of our products, are at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our local Quality Assurance Team, we are currently looking for a Quality Assurance Specialist.   Position summary The Quality Assurance Specialist carries out the necessary tasks to keep the Quality System up to date and efficient under the instructions of the Quality Assurance Manager at all production sites.   Essential tasks and responsibilities - Analysis and evaluation of data through monitoring and measurements; handling of complaints and deviations in order to take improvement actions, identify problems and propose corrective solutions. - Qualification of the suppliers of finished and semi-finished products, materials and raw materials as well as the status verification of the qualified supplier. - Drawing of Master Batch Records, validation protocols and final validation and qualification reports, execution of batch record reviews. - Definition of the operational procedures and documents required to maintain GMP compliance along with the other units/department managers involved. - Definition of staff training plans and coordination of training and education activities. - Participation in internal investigations, implementation of corrective and preventive actions along with the other managers involved. - Involvement in the coordination of inspections and audits by third parties and assistance to the Quality Assurance Manager.   Required skills and core competences - Bachelor/Master Degree in Technical Science or related subjects (chemistry, pharmacy, engineering and so on) - 5-7 years' experience in the pharmaceutical field, production or quality assurance. - Competences in GMP regulations. - Experience in injectable anesthetics and terminally sterilized products. - Fluent written and spoken English, knowledge of French will be considered an asset. - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude. - Management and organizational skills, flexibility, learning agility and strategic thinking. - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young, dynamic work environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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04/02/2021
TOTAL 16

Total jobs:

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