Beschreibung
You have in-depth experience in Quality Assurance (QA) in the pharmaceutical industry and are looking for a jump to an international biotech company in Munich? Then the following role should be very interesting for you:(Senior) Manager Quality Assurance (m/f/d)
Your Responsibilities:
- Plan, perform and follow-up audits of external Contract Manufacturing/Contract Testing Organizations
- Support CMC department in selecting external CMO/CTO
- Setting-up of Quality-Technical Agreements (QTA) including negotiating with CMO/CTO, and external Pharmacies, update of existing QTA
- Set-up batch release processes for clinical trial material produced outside EU for use in clinical trials conducted world-wide
- Managing of GMP deviations, changes, out-of-specifications occurring at external CMO/CTO
- CAPA Management
Your Profile:
- Professional experience in GMP Quality Assurance within (bio)-pharmaceutical industry
- Sound knowledge in international regulations and guidelines (EU / FDA cGMP regulations, GDP guidelines, ICH etc.)
- Sound background in bioprocessing is a plus
- Able to work independently and solution-oriented
- Well-organized, structured person with attention to detail
- Excellent communication skills, fluent in English (written and spoken)
- Flexible, highly motivated, with strong organization skills
- Team player with well-developed interpersonal abilities
- Excellent application of office software (Word, Excel, PowerPoint and SharePoint)
Are you interested in this place? Then I look forward to your application.
Best wishes,
Stefan Blöchl