Chief Quality Assurance Officer

1 week ago

Alwar, Rajasthan, India beBeeQuality Full time ₹ 22,00,000 - ₹ 28,10,000
Job Description
The Head of Quality Assurance plays a vital role in ensuring the organization's products meet the highest quality standards. This involves developing, implementing, and maintaining Quality audit systems, GMP quality systems, and Behavioural GMP aspects.

Key Responsibilities:
  • Develop, implement, maintain, and improve Quality audit, 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.
  • Responsible for CAPA close out for all audits and inspections.

Required Skills and Qualifications:
  • Quality Management System (QMS): Establish a robust QMS to manage and implement change management, Deviation management, Incidents, complaint handling, and CAPA management.
  • GMP Training and Compliance: Develop, maintain, and improve a GMP compliant document control system, ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company.
  • Data Integrity and Validation: Ensure all validation activities (process/cleaning/method/equipment etc.) are carried according to approved protocols and requirements.
  • Regulatory Affairs: Well-versed with requirements of Injectable products, facility requirements, and Media fill requirements.

Benefits:
  • A competitive compensation package.
  • A dynamic and supportive work environment.
  • Opportunities for career growth and professional development.

Others:
  • 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 Company maintains a state of readiness for inspection by regulatory agencies.
  • Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
  • Lead, manage, and ensure proper training to any relevant change management programs throughout the company.

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