Role Summary To own the QA-side of QC operations audit-trail review, OOS / OOT investigation oversight, lab-incident handling, lab self-inspection, and Lab QA documentation ensuring QC compliance with cGMP, GLP, ALCOA+, and 21 CFR Part 11.

Key Responsibilities

1. Audit-Trail Review & Data Integrity

- Perform and oversee audit-trail reviews of QC instruments, including HPLC, GC, IR, UV, KF, balances, dissolution apparatus, and stability chambers, as per approved SOPs.
- Review computerized system audit trails for ALCOA+ compliance and identify data integrity concerns, discrepancies, or unauthorized activities.
- Maintain audit-trail review registers and ensure timely escalation and investigation of non-compliances.

2. OOS / OOT Investigations & Laboratory Incidents

- Review and oversee OOS/OOT investigations (Phase IA, IB, II, and III) initiated by QC.
- Review laboratory incidents, including instrument breakdowns, data deletion, calibration failures, and other laboratory deviations.
- Ensure appropriate Root Cause Analysis (RCA), CAPA implementation, and timely closure in coordination with QC and QMS teams.

3. Laboratory QA Monitoring & Self-Inspection

- Conduct routine Lab QA walkthroughs and self-inspections across QC laboratory sections.
- Monitor instrument logbooks, balance verification, mobile-phase preparation, glassware cleaning, and laboratory documentation practices.




- Identify compliance gaps, ensure corrective actions, and monitor closure of observations.
- Maintain self-inspection trackers and ensure QC laboratory audit readiness.

4. QMS & Documentation Management

- Oversee QMS activities related to deviations, OOS, OOT, and laboratory incidents.
- Ensure proper documentation and record maintenance through the Electronic Document Management System (eDMS).
- Maintain audit-trail review registers, investigation files, laboratory incident registers, and self-inspection records.
- Ensure documentation compliance with ALCOA+ principles.

5. Regulatory Compliance & Audit Support

- Ensure compliance with cGMP, GLP, ICH Q9 / Q10, 21 CFR Part 11, EU Annex 11, and applicable Schedule M requirements.
- Support and participate in internal audits, customer audits, and regulatory inspections.
- Drive continuous improvement in laboratory quality systems and data integrity practices.

Job Requirement

- OSD pharmaceutical manufacturing experience mandatory.
- Solid hands-on experience in audit-trail reviews, OOS/OOT investigations, laboratory incidents, and data integrity.
- Proven experience in independently managing QC laboratory QA activities and ensuring cGMP compliance.
- Experience in RCA, CAPA management, audits, regulatory inspections, and laboratory self-inspections.

📌 Assistant Manager - Lab QA (Palghar)
🏢 Pelltech Healthcare
📍 Palghar