Senior Officer Executive - Quality Control
The Senior Officer / Executive – Quality Control will manage analytical testing, instrument handling, documentation review, and laboratory compliance activities in a pharmaceutical quality control environment. The role involves supervising QC operations, reviewing analytical data, supporting investigations, ensuring GLP and GMP compliance, and coordinating with cross‑functional teams for timely product release and regulatory inspection readiness.
Role & Responsibilities
- Supervise routine and non‑routine QC testing activities for raw materials, finished products, in‑process, and stability samples.
- Review analytical worksheets, chromatograms, raw data, calculations, and laboratory records for accuracy and compliance.
- Ensure proper operation, calibration, qualification, and maintenance of analytical instruments.
- Guide junior analysts in testing procedures, documentation practices, and laboratory safety.
- Investigate OOS, OOT, deviations, laboratory incidents, and analytical failures with proper root cause analysis.
- Support CAPA implementation, change control, risk assessment, and other QMS‑related activities.
- Ensure compliance with GLP, GMP, data integrity, pharmacopeial standards, and regulatory guidelines.
- Coordinate with QA and production teams for sample analysis, batch release, and investigation closure.
- Support analytical method validation, verification, transfer, and troubleshooting activities.
- Monitor stability testing schedules and ensure timely analysis and documentation.
- Maintain laboratory inventory of chemicals, reagents, reference standards, columns, and consumables.
- Prepare and review SOPs, specifications, test methods, and analytical protocols.
- Participate in internal audits, customer audits, and regulatory inspections.
- Ensure safe laboratory practices and proper waste disposal as per EHS guidelines.
- Drive continuous improvement in laboratory productivity, documentation quality, and compliance standards.