Job Description

Essential Functions


Plan and supervise preventive maintenance, calibration, and verification of QC instruments. Ensure timely release of raw materials, intermediates, and packing materials as per approved specifications. Maintain strict compliance with GLP, safety protocols, and laboratory housekeeping. Prepare and review stability protocols, monitor sample charging/withdrawal, and approve stability reports. Investigate deviations, OOS, OOAL, and incidents; implement effective CAPA. Review and approve QC-related change controls, SOPs, and specifications. Conduct audit trail reviews and ensure electronic data integrity for software-enabled instruments. Oversee LIMS operations and ensure accurate documentation and traceability. Identify training needs and support skill development for QC personnel. Manage analytical column inventory and laboratory standards as per SOPs. Additional Responsibilities


Support internal/external audits and regulatory inspections. Drive continual improvement initiatives in QC processes and compliance. Perform any additional assignments allocated by QC Head/Designee.

Skills:


GLP & GDP Compliance - Advanced Stability Study Management - Advanced Data Integrity & LIMS Operations - Advanced Deviation/OOS Investigation - Advanced Regulatory Compliance & Documentation - Advanced Leadership & People Development - Advanced

Other Skills:

Laboratory Data Management - Advanced Stability Study Documentation - Advanced Specifications & Test Methods Documentation - Advanced Analytical Method Validation Documentation - Advanced CAPA, Deviation, and Change Control Management - Advanced Training and Compliance Record Management - Advanced Knowledge of Regulatory guidelines/Requirement - Advanced Analytical evaluation of vendor - Advanced Method Validation/verification Protocol Design/review - Advanced GMP Compliance for Environmental Monitoring - Advanced Documentation & Data Integrity Practitioner - Advanced CAPA, Deviation, and Change Control Management - Advanced Specifications & Test Methods Documentation - Advanced

Specialized Knowledge: Licenses:

Qualifications


Education:


M.Sc / M.Pharm / B.Pharm - Chemistry or related discipline preferred.
Experience:


* 12+ years of experience in QC operations within API manufacturing.