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
QUALIFICATIONS
Education
- M.Sc / M.Pharm / B.Pharm Chemistry or related discipline preferred.
Experience
- 1-5 years of hands-on experience in QC operations within an API manufacturing facility.
