Director of Compliance and Quality Assurance

5 days ago


Nagpur, Maharashtra, India beBeeLeadership Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Quality Assurance Leader

This position is responsible for the overall quality and compliance of our products with regulatory requirements.

  • Develop, implement, maintain, and improve Quality audit, 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.
Key Qualifications
  • 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 programmes.
  • 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).
Additional Responsibilities
  • Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the organization.
  • To 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 organization maintains a state of readiness for inspection by regulatory agencies.
  • Lead, manage, and ensure proper training to any relevant change management programs throughout the organization.

This role requires strong leadership and technical skills, including knowledge of GMP regulations and quality management systems.

The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively in a team environment. A strong understanding of quality management principles and experience in a similar role would be advantageous.

Professional certification or qualifications such as CQA or CQM would also be beneficial.



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