Lab Qa Executive

Job description

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.