(Senior) Quality Assurance Manager
Vor 4 Tagen
Date: Oct 11, 2024
Location: Basel, Switzerland, 4010
Job Id: 58305
Mepha Pharma AG and Teva Pharma AG are among the leading pharmaceutical companies in Switzerland. Since 2011, Mepha is part of the internationally active Teva Group, one of the world's leading suppliers of generics. Mepha and Teva are based in Basel and currently employ 174 people in total. The portfolio of Mepha and Teva comprises over 320 products, primarily used in primary care to treat a wide range of diseases.
Business PurposeMepha Schweiz is currently looking for a Senior Quality Assurance Manager to support the Commercial Quality Team. In this role, you will ensure GMP&GDP compliance by improving and maintaining the processes and documents of the quality management system and contribute to audits and inspections. You will perform the release of products of Mepha’s portfolio to the Swiss market and manage quality incidents, new product launches, complaints, deviations, and change control procedures. You will act as Deputy of the Responsible Person (RP) and represent the Commercial Quality Unit Team in cross-functional projects.
Main Responsibilities- Perform Swiss market releases in delegation of the RP, including deviation and change control management
- Act as Deputy RP (Stv. FvP)
- Lead the management of quality incidents, complaints and recalls
- Review PQRs
- Manage Quality Technical Agreements
- Create and maintain Standard Operating Procedures and Working Instructions, and contribute to the continuous improvement of processes and to trainings
- Contribute to authority inspection readiness, support local authorities’ inspections, and perform internal audits
- Represent Swiss QA in Teva’s European Commercial Quality organization
- Lead or participate in internal project teams or working groups
- Collaborate with local functions, e.g. Regulatory Affairs, Pharmacovigilance, Supply Chain, Customer Services as well as internal and external suppliers
- You have a Master’s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education
- You have a minimum of 7 years of working experience in a pharmaceutical company; including a minimum of 5 years in a QA/QC function, ideally including Swiss market release
- In-depth knowledge of quality assurance and process organization within the pharmaceutical industry
- Knowledge of GMP/GDP guidelines of the European and Swiss pharmaceutical legislation
- Experience in matrix leadership
- Proficient computer skills in current software including MS Office
- Excellent German and English language skills
- You are a communicative team player
- Being quality conscious, you pay attention to details, and work systematically
- You are proactive and open to changes
- Opportunity to engage in an interesting, varied, and exciting role within a dynamic team in a growing organization with an international scope
- Enjoy versatile and challenging work that provides valuable insights into various business processes
- Benefit from progressive perks such as a lunch card and public transport allowance
- Work at our central office, just a few minutes' walk from Basel SBB train station, ensuring easy commutes
Quality
Reports ToHead Quality Assurance
Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.
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