
QA Officer
- Anklesvar, Gujarat
- Permanent
- Full-time
- Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support.
- Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications and data integrity (ALCOA+).
- QMS Ownership: Manage change controls, deviations, CAPA, OOS/OOT investigations with timely closure and impact assessment.
- Documentation Control: SOPs, specifications, STPs, protocols/reports; version control and archival as per GDP.
- Vendor & Material Quality: Support qualification, sampling, and release of RM/PM; review COAs and ensure traceability.
- Training & Compliance: Conduct/track GMP and GDP trainings; maintain training matrices.
- Quality Risk Management: Participate in risk assessments (FMEA/HACCP) and mitigation plans.
- Change Implementation: Partner with Production, QC, and Engineering to implement approved changes without compliance gaps.
- Metrics & Reporting: Maintain QMS KPIs; present trends to management.
- EHS & Data Integrity: Enforce site safety and DI requirements; escalate non‑compliances.
- Must be excellent in written and spoken English; net savvy and adept at computer skills
- Attention for detail
- Team player
- Good in communication
Current CTC :-
Expected CTC :-
Notice Period :-