Role & responsibilities

- Ensure compliance of laboratory activities with GMP, GLP, data integrity, and regulatory requirements.

- Review and approve analytical reports, raw data, specifications, SOPs, protocols, and laboratory records.

- Investigate and manage OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.

- Perform root cause analysis (RCA) and monitor implementation and effectiveness of CAPA.

- Review and approve change controls, risk assessments, and quality impact assessments related to laboratory operations.

- Conduct internal audits and support regulatory inspections by FDA, MHRA, WHO, and customer audits.

- Ensure timely calibration, qualification, and maintenance compliance of laboratory instruments and equipment.

- Monitor training compliance of laboratory personnel and ensure adherence to approved procedures and quality systems.





- Maintain and improve the Laboratory Quality Management System (LQMS) through periodic reviews and compliance monitoring.

- Coordinate with QC, Production, Regulatory Affairs, and other cross-functional teams to ensure product quality and regulatory compliance.

Preferred candidate profile

- Qualification: M.Sc. (Chemistry/Microbiology) or B.Pharm/M.Pharm.

- Experience: 5-10 years in Pharmaceutical Quality Assurance, preferably in Laboratory QA.

- Solid knowledge of GMP, GLP, Data Integrity, CAPA, Change Control, OOS/OOT Investigation, and Regulatory Guidelines.

- Experience in handling regulatory audits and laboratory compliance activities.

- Good communication, documentation, and problem-solving skills.

📌 Lab Qa Executive (Paonta Sahib)
🏢 Mankind Pharma
📍 Paonta Sahib