Job Description
The Senior Officer – QC (Validation) will be responsible for testing and analysis of sample to ensure compliance .
Perform validation activities for QC instruments, equipment, and analytical methods as per regulatory guidelines (USFDA, EU, ICH).
Execute calibration, qualification (IQ/OQ/PQ), and periodic review of QC laboratory equipment.
Prepare and review validation protocols, reports, and related SOPs.
Ensure compliance of analytical methods with current pharmacopeia requirements (USP, EP, BP, IP).
Support analytical method transfer and method validation activities.
Participate in investigations, deviations, OOS/OOT results, and CAPA implementation related to validation.
Maintain documentation and records in line with cGMP and data integrity requirements.
Coordinate with cross-functional teams during audits and regulatory inspections.
Train QC staff on validation-related procedures and updates.