Senior Quality Assurance Manager

2 days ago

Belgaum, Karnataka, India beBeeQuality Full time ₹ 1,72,45,000 - ₹ 2,42,70,000

**Job Title:** Quality Assurance Lead

We are seeking an experienced professional to lead our quality assurance team and ensure the highest standards of product quality.

  • Responsibilities:
  • Develop and implement quality audit programs, maintain 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.
  • 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.
  • All GMP trainings and Quality training programme.
  • Oversee investigations of all non-conformances (deviations, complaint etc.).
  • Product Recall.
  • Create and maintain system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System).
  • cGMP requirements and quality standards recognized, understood, and maintained across the Company.
  • 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.

Required Skills and Qualifications:

A strong background in quality assurance, preferably with experience in pharmaceuticals. Excellent communication and leadership skills. Ability to work in a fast-paced environment and prioritize multiple tasks.

Benefits:

A competitive salary and benefits package, including health insurance, retirement plan, and paid time off. Opportunities for career growth and development.

Others:

A dynamic and collaborative work environment, with a team of professionals dedicated to delivering high-quality products. A commitment to ongoing learning and professional development.

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