Quality Assurance Specialist - Pharma | Spezialist Qualitätssicherung (m/w/d) - Pharma
betapharm Arzneimittel GmbH
Job Summary
This role is for a dedicated Quality Assurance Specialist within the pharmaceutical industry, focusing on EU-level quality processes. The successful candidate will be responsible for managing all administrative aspects of Product Quality Reviews (PQRs) and product stability data. Key duties include overseeing the entire administrative process from ordering to reporting, analyzing key performance indicators, and handling product complaints, especially pre-market release and market complaints, in collaboration with internal and external partners. The specialist will also actively participate in and potentially lead local and EU-wide QA projects, conduct self-inspections, and manage SOPs within an electronic document management system. This position is ideal for a detail-oriented professional with a scientific or technical background and significant experience in a regulated environment.
Required Skills
Education
Completed scientific or technical education, ideally a university degree or comparable qualification
Experience
- Several years of professional experience in Quality Assurance, preferably in a regulated environment like the pharmaceutical industry
- Good knowledge of GMP-relevant processes and documentation
Languages
Additional
- Not specified