- Data Review: Audit and approve raw data, calculations, and analytical records for APIs, stability, and raw materials.
- Audit Trails: Perform mandatory reviews of electronic instrument audit trails (Empower 3) to prevent data gaps or manipulation.
- QMS Investigations: Leading phase-1 laboratory investigations for OOS, OOT, and deviations.
- Audit Readiness: Maintain logs, instrument calibrations (HPLC, GC), and procedures to remain continuously ready for USFDA inspections.
Preferred candidate profile 8 to 10 years QC experience in a QC USFDA-approved API plant.