QC - Validation - Sr Officer
QC - Validation - Sr Officer
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Job Description
Analytical Method Validation (AMV): Perform method validation verification and transfer for pharmaceutical products as per ICH guidelines.
Instrument Handling & Calibration: Operate and maintain HPLC GC UV FTIR and dissolution apparatus ensuring compliance with calibration and system suitability requirements.
Regulatory Compliance & Documentation: Prepare and review validation protocols reports and method transfer documents ensuring adherence to USFDA MHRA WHO and EUGMP guidelines.
OOS & Deviation Investigation: Identify and investigate outofspecification (OOS) results deviations and laboratory incidents implementing CAPA.
Stability Studies Support: Assist in stability testing as per ICH guidelines ensuring method robustness and reproducibility.
Audit Readiness: Maintain accurate AMV documentation and support regulatory inspections and internal audits.
Required Experience:
Senior IC
Employment Type
Full-Time
