Related skills
capa cgmp analytical method validation qc data review oos investigations📋 Description
- Provide QA review/approval of policies, procedures and QC documents (methods, specs, protocols, reports).
- Verify QA data for release and stability; ensure QC completes technical review before QA review.
- Support/approve lot disposition decisions from QC data package.
- Oversee method validation, verification, transfer (internal/external CTLs), finalization and implementation.
- Ensure alignment between approved specifications and validated methods.
- ALCOA+ principles applied in QC; oversee change controls, deviations, OOS/OOT/OOE, CAPAs and risk.
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