Senior QA Specialist, QA Operations 80-100% (f/m/d)
Core
Senior QA Specialist ensuring quality assurance during the transition from clinical to commercial production in a GMP manufacturing facility.
Role type
Senior QA Specialist (GMP Manufacturing)
Builds
Pharmaceutical batches and quality operations
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
GMP compliance, risk-based approaches (FMEA), computer systems (TW, SAP), process event decision-making, audit participation
Preferred skills
Tech transfer experience
Responsibilities
Manage QA tasks during clinical-to-commercial transition, assess and manage tasks impacting quality operations, plan and coordinate activities with QC/Engineering/Manufacturing, review GMP records for cGMP compliance, make real-time process decisions on the floor, participate in walkthroughs and audits
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