QA OF QC

Job description

Role & responsibilities -Ensure compliance with GMP, safety norms, company policies, and Good Laboratory Practices (GLP). -Review and approve analytical reports for intermediates, APIs, drug substances, stability studies, and instrument calibration. -Oversee UnitII stability and API reports, working/reference standards, and Certificates of Analysis (COA). -Manage laboratory incidents, outofcalibration investigations, and controlled QC documentation. -Review continuous process verification data, audit trails in laboratory software, and user access privileges. -Conduct pharmacopoeia evaluations, specifications, and standard testing procedures. -Coordinate documentation for Drug Master File (DMF) filings. -Validate laboratory instruments, equipment, and software systems. -Support technology transfer, change management, and risk assessment activities. -Review trend analysis reports, stability summaries, miscellaneous protocols, and training evaluations. -Initiate, track, and close Corrective and Preventive Actions (CAPA) in Trackwise. -Collaborate with crossfunctional teams to ensure regulatory readiness and continuous improvement. Preferred candidate profile Qualification - Msc Chemistry Experience - 4 to 10 Years