GMP Expert, Media Production | Biotechnologe (m/w/d)
PromoCell GmbH
Job Summary
This role is for a GMP Expert to join the Media Production team in Heidelberg, Germany. The successful candidate will be responsible for reviewing and implementing GMP-relevant customer requirements within the media production department, significantly contributing to the company's success. Day-to-day tasks include supporting the advisory team with customer inquiries, developing GMP-compliant manufacturing processes (EXCiPACTTM GMP Standard), creating validation and qualification documents, and leading projects for new GMP process introductions. The role also involves applying QRM methods like FMEA, assisting with regulatory documents (e.g., Drug Master File), and participating in internal and external audits. This position is ideal for a professional with a scientific or technical master's degree and relevant GMP experience in a regulated environment.
Required Skills
Education
Master's degree in a scientific or technical field (Biotechnology, Bioengineering, Bioprocess Engineering) or equivalent qualification with GMP experience
Experience
- • 2-3 years of professional experience in reagent manufacturing in a regulated environment
Languages
Additional
- Not specified
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