Assistant Manager - Lab QA

Pelltech Healthcare; Wada; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Pelltech Healthcare in Maharashtra invites applications for a QA/QC role focused on audit-trail review, OOS/OOT investigations, and lab incident handling to ensure cGMP, GLP, ALCOA+ and 21 CFR Part 11 compliance.

You will oversee data integrity, QMS activities, and EDMS documentation, coordinate with QC and regulatory teams, and drive continuous improvement in laboratory quality systems.

Qualifications

• OSD pharmaceutical manufacturing experience preferred.
• Hands-on experience in audit-trail reviews and data integrity.
• Experience coordinating RCA, CAPA, audits, and regulatory inspections.

Responsibilities

• Lead audit-trail reviews for QC instruments and data systems.
• Oversee OOS/OOT investigations and lab incidents with RCA and CAPA.
• Conduct lab QA walkthroughs and self-inspections, ensuring documentation readiness.
• Manage QMS activities related to deviations, investigations, and incidents.
• Ensure documentation with ALCOA+ principles and eDMS compliance.

Skills

Audit-trail reviews

Data integrity

OOS/OOT investigations

Lab incidents handling

cGMP/GLP compliance

ALCOA+

21 CFR Part 11

Education

Bachelor's degree in Pharmaceutical Quality Assurance

Tools

eDMS

Job description

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.
• Strong 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.