Essential Functions
JOB DESCRIPTION
- 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 – AdvancedStability Study Management – AdvancedData Integrity & LIMS Operations – AdvancedDeviation / OOS Investigation – AdvancedRegulatory Compliance & Documentation – AdvancedLeadership & People Development – AdvancedOther Skills
Laboratory Data Management - AdvancedStability Study Documentation - AdvancedSpecifications & Test Methods Documentation - AdvancedAnalytical Method Validation Documentation - AdvancedCAPA, Deviation, and Change Control Management - AdvancedTraining and Compliance Record Management - AdvancedKnowledge of Regulatory guidelines / Requirement - AdvancedAnalytical evaluation of vendor - AdvancedMethod Validation / verification Protocol Design / review - AdvancedGMP Compliance for Environmental Monitoring - AdvancedDocumentation & Data Integrity Practitioner - AdvancedCAPA, Deviation, and Change Control Management - AdvancedSpecifications & Test Methods Documentation - AdvancedSpecialized Knowledge : Licenses :
Qualifications
QUALIFICATIONS
Education
M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.Experience
12+ years of experience in QC operations within API manufacturing.Skills Required
Training and Compliance Record Management, Deviation OOS Investigation, Analytical Method Validation Documentation, Method Validation verification Protocol Design review, GLP GDP Compliance, Specifications Test Methods Documentation, Data Integrity LIMS Operations, Documentation Data Integrity Practitioner, Laboratory Data Management, CAPA Deviation and Change Control Management, Stability Study Management, Regulatory Compliance Documentation, Stability Study Documentation, Knowledge of Regulatory guidelines Requirement, Analytical evaluation of vendor, GMP Compliance for Environmental Monitoring