QA - Officer/Executive - IPQA - LVP

Department: Quality Assurance
Reporting To: Manager – QA / Production
Experience: 2–5 Years
Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc.
Shift: Three-shift operation

Job Summary

Responsible for monitoring manufacturing activities to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves line clearance, in-process monitoring, batch record verification, and accurate documentation to ensure consistent product quality and regulatory compliance.

Key Responsibilities

• Monitor and supervise manufacturing activities in accordance with cGMP, approved SOPs, and regulatory guidelines.
• Perform line clearance before start-up, during changeovers, and after batch completion.
• Verify and review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for accuracy, completeness, and compliance.
• Ensure all manufacturing operations are executed strictly as per approved MFR (Master Formula Record).
• Perform and document in-process checks (IPC) during various stages of manufacturing.
• Ensure timely and accurate documentation of manufacturing activities in logbooks, batch records, and related formats.
• Identify, document, and escalate deviations or non-conformances to QA/Production management.
• Ensure adherence to data integrity and GDP practices during documentation.
• Coordinate with Production, QA, and QC teams to maintain smooth manufacturing operations.
• Work effectively in three-shift operations as per production requirements.
• Support internal and external audits and inspections related to manufacturing activities.

Key Skills & Competencies

• Strong knowledge of cGMP and regulatory requirements
• Hands-on experience in line clearance and in-process monitoring
• Sound understanding of BMR, BPR, and MFR
• Good documentation and compliance orientation
• Attention to detail and analytical skills
• Ability to work in rotational shifts

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹45,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person