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Quality Assurance Leader for APIs and Biologics
vor 1 Woche
We are looking for a Quality Assurance Leader for APIs and Biologics to join our team at Corden Pharma GmbH. The successful candidate will be responsible for ensuring the quality of our APIs and biologics.
About the Role- You will be responsible for collaborating with local quality departments to ensure GMP readiness of new and legacy API facilities.
- You will work closely with cross-functional teams to ensure quality operations compliance with local and global quality regulations.
- You will conduct KPI surveillance and internal audits to identify areas of risk or concern for API production.
- You should have a university degree in Chemistry, Pharmacy, Biology, Engineering or other technical/natural scientific area.
- You should have minimum 5-8 years of work experience in manufacturing, quality control, quality assurance or other relevant area, in an API producing pharmaceutical/CDMO company.
- You should have profound knowledge of EU GMP and FDA regulations.
