Head of Quality Assurance and Compliance
1 week ago
As a Quality Assurance Leader, you will be responsible for spearheading the quality function, implementing rigorous audit processes, and maintaining compliance with Good Manufacturing Practice (GMP) standards. You will work closely with cross-functional teams to ensure that our products meet the highest quality standards and are delivered to the market on time.
Key Responsibilities:- Develop, implement, maintain, and improve quality audit processes, GMP quality systems, and Behavioural GMP aspects.
- Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, and any other outsourced activities, internal audits, compliance audits.
- 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 programs.
- Oversee investigations of all non-conformances (deviations, complaints, etc.).
- Responsible for handling Product Recall.
- Create and maintain systems 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.
- To develop batch Release and Reject systems to ensure quality products are 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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