Quality Assurance Specialist
1 week ago
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
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