QA Specialist Manufacturing (m/w/d) - Schwerpunkt Batch Record Review
Core
Ensuring GMP compliance and quality oversight at the interface between production and quality assurance for sterile injectable pharmaceuticals.
Role type
Manufacturing QA Specialist (Batch Record Review)
Builds
Sterile injectable drugs (oncology therapeutics) and related delivery systems
Domain
Pharmaceutical manufacturing (sterile/aseptic) + Regulatory Compliance (EU-GMP, FDA)
Required skills
cGMP regulations knowledge, Batch record review, Audit trail review, Deviation reporting, Data entry, SOP adherence
Preferred skills
Aseptic manufacturing experience, eQMS systems (Veeva, Trackwise)
Technologies
Veeva, Trackwise
Responsibilities
Review Master Batch Records for sterile/aseptic products, Verify GMP compliance per EU-GMP and FDA standards, Review manufacturing protocols including sterilization and aseptic filling, Check variable data in packaging protocols before production release, Report deviations and support root cause analysis, Enter data for KPI collection and cycle time tracking
Seniority
Mid-level, hands-on IC
