(Senior) Quality Assurance Manager (m/f/d) and Deputy RP 80%
About Mepha and Teva in Switzerland
Mepha Pharma AG and Teva Pharma AG are together 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, which are primarily used in primary care to treat a wide range of diseases.
The range includes about 270 generics, over-the-counter medicines, dietary supplements, medical products, biosimilars, biologicals and other original medicines.
The latter are used to treat diseases of the central nervous system, the respiratory tract and cancer. Mepha and Teva distribute their products via pharmacies, self-dispensing doctors, wholesalers and hospitals.
With around 23 million* packs, Mepha and Teva sold the most medicines in Switzerland in 2023.
Business Purpose
Mepha 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
- Manage major product launches
- 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
Your experience and qualifications
- You have a Master s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education
- You have 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
- To give us a complete picture of your professional profile, please send us your full application with the following documents : CV, letter of motivation, school certificates and reference letters / testimonials.
What we offer
- 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
Fuction
Quality