Quality Assurance Specialist (Pharma, GMP, GLP) | PTA (m/w/d)
Analytisches Zentrum Biopharm GmbH
Job Summary
AZ Biopharm GmbH, a company with over 20 years of experience in pharmaceutical quality control under GMP and bioanalysis under GLP/GCP, is seeking a dedicated Quality Assurance Specialist for their Berlin location. In this full-time role, you will be responsible for planning, executing, and documenting equipment qualifications (DQ/IQ/OQ), re-qualifications, and periodic reviews within a GMP-regulated environment. You will also create and maintain quality-relevant documents such as SOPs and reports, collaborate with various departments and external vendors, and support audits and inspections. The ideal candidate possesses a strong understanding of regulatory requirements (GMP, ideally GLP), practical experience in equipment qualification, and a structured, quality-oriented work approach. This position offers a positive work environment in a growing company within a dynamic market, flexible working hours, and excellent public transport links.
Required Skills
Education
University degree or vocational training in a scientific, pharmaceutical, or technical field
Experience
- Practical experience in the qualification of laboratory equipment (DQ/IQ/OQ)
- Experience with re-qualifications and periodic reviews
- Professional experience in a GMP-regulated environment
- Experience in creating, reviewing, and maintaining quality-relevant documentation (SOPs, qualification plans, reports)
- Experience collaborating with technical departments, Quality Assurance, and external service providers
Languages
Additional
- Not specified