Role & responsibilities

-Ensure compliance with GMP, safety norms, company policies, and Valuable 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

📌 QA OF QC (Ankleshwar)
🏢 Zydus Lifesciences
📍 Ankleshwar