QA Compliance Lead

Core Purpose of the Role :

Experience - 8 to 10 years

• Line Clearance process overview, Product change over.
• Timely area readiness (Cleaning, EMS, OOS status) and ensures availability of documents and material status.
• Monitoring of process through process step verification.
• Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions.
• Equipment / utility Qualifications, Calibrations, PM verification.
• Utility / Computer system validation
• Process validation and cleaning validation.
• Target Monitoring for batch related process activities.
• cGMP compliance and verification overview of BMP facility & Utilities.
• SOP preparation and review.
• Training
• GEMBA principles
• Quality management system, investigatio