Lab Qa Executive

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.
• Strong 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.