Job Description
Officer – Quality Control is responsible for executing and supporting routine QC laboratory activities, including analysis, documentation, and compliance with cGMP and GLP requirements. The role involves handling raw material, in-process, and finished product testing, supporting stability studies, maintaining instrument compliance, and assisting in deviation/OOS investigations. The position also supports data integrity, SOP adherence, and continuous improvement initiatives within the QC function.
Essential Functions – Officer, Quality Control
- Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
- Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
- Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
- Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
- Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
- Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
- Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
- Enter, verify, and maintain accurate analytical data and sample status in LIMS.
- Participate in training programs and support knowledge sharing within the QC team.
- Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.
Qualifications
Education
- M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.
Experience
- 1-6 years of hands-on experience in QC operations within an API manufacturing facility.
