QA/ra Associate

vor 2 Wochen

Zurich, Schweiz Hays Vollzeit

**My duties**
- Batch record review and continuous product quality follow-up
- PQR management
- Assessing deviation reports received from CMOs
- Support handling, responding, tracking of complaints received from customers
- Participate in internal and CMO audits incl. CAPA follow-up and (re-)audit coordination
- Evaluate change requests received from CMO/CRO/API manufacturer from a regulatory affairs and GMP point of view
- Initiate internal change requests
- Product dossier updates, review of updates received from CRO/CMO or regulatoryservice providers, identification of deficiencies
- Participate in development of variation submission strategy for finished products
- Track submitted variations in different countries and by different customers
- Keep internal databases updated
- Release of secondary packaging specification
- Release of secondary packaging technical check

**My qualifications**
- Scientific background with a BSc or higher in Life Sciences
- Working experience in a QA- or production-related role at a manufacturing site of medicinal products
- Additional working experience in regulatory affairs tasks of FDF is an asset
- Eager to work within a framework of regulations like GMP/GDP/GxP
- Proficiency in English is a must, knowledge in German is of advantage

**My benefits**
- You will become a member of a highly qualified and motivated FDF & Dossier Business Team. This newly created position is designed to further increase the capacities and gives you the opportunity to strengthen your QA knowledge and to grow into Regulatory Affairs activities. The company offers a great team spirit in an international working environment, which is paired with a Swiss style of doing business like reliability, continuity and quality.

**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**

**Reference number**
626445/1

**Contact**
Phone:
+41 44 225 50 00

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