
Senior Manager Quality Assurance
5 days ago
We are seeking a Quality Assurance professional to lead our team and drive the implementation of quality management systems. The ideal candidate will have experience in developing and maintaining GMP compliant document control systems, coordinating vendor qualification activities, and ensuring regulatory compliance.
">Key Responsibilities:
- Develop, implement, maintain, and improve Quality audit and GMP quality systems
- Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, and any other outsourced activities
- Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections
- Responsible for CAPA close out for all audits and inspections
- Develop, maintain, and improve a GMP compliant document control system
- Establish a robust Quality Management System (QMS) to manage and implement change management, Deviation management, Incidents, complaint handling, and CAPA management
- Responsible for All GMP trainings and Quality training program
- Oversee investigations of all non-conformances (deviations, complaint etc.)
- Responsible for handling Product Recall
- Create and maintain system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
- Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company
- Develop batch Release and Reject system to ensure quality product is released to the market
- Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
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