Quality Assurance Specialist

5 days ago

Surat, Gujarat, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Senior Quality Systems Manager

The ideal candidate will oversee and implement quality systems, ensuring compliance with regulatory requirements and industry standards.

  • Develop, implement, maintain, and improve quality audit and GMP systems.
  • Coordinate vendor qualification activities and ensure inspections are properly finalized.
  • Responsible for CAPA close-out and maintaining a robust document control system.

This is a senior leadership role that requires strong communication and project management skills. If you have experience leading quality initiatives and are passionate about ensuring high-quality products, we encourage you to apply.

The successful candidate will lead the development of a quality management system (QMS) to manage change management, deviation management, incidents, complaint handling, and CAPA management. They will also be responsible for all GMP trainings and quality training programs, overseeing investigations of non-conformances, and handling product recalls.

Key responsibilities include:

  • Ensuring data integrity through internal audits, training, and review.
  • Maintaining and improving departmental operational performance, meeting requirements of regulatory authorities, SOPs, and external/internal customers.
  • Developing, implementing, and maintaining quality systems, adhering to GMP, company SOPs, and Health and Safety policies.

The ideal candidate must be well-versed in quality regulations, including ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System). They will work closely with cross-functional teams to ensure the organization maintains a state of readiness for inspection by regulatory agencies.

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