Senior Quality Assurance Specialist

3 days ago


Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 70,000 - ₹ 1,30,000
Job Title:

Head of Quality Assurance and Compliance

The Head of Quality Assurance and Compliance will be responsible for leading the quality function across R&D and manufacturing operations.

  • Ensure that all R&D and manufacturing operations meet global regulatory requirements.
  • Foster a culture of quality ownership, data integrity, and right-first-time execution across R&D and manufacturing.

Quality Systems and Regulatory Compliance

Establish and maintain a robust quality management system (QMS) to comply with ICH, USFDA, EMA, MHRA, OECD-GLP, and cGMP requirements.

Lead and oversee GMP/GLP compliance across laboratories and manufacturing operations.

Plan and manage internal audits, customer audits, and regulatory inspections to ensure timely closure of observations and effective CAPA management.

Oversee change control, deviation management, OOS/OOT investigations, and document control for both R&D and manufacturing units.

R&D and Manufacturing Interface

Provide quality oversight for technology transfer and ensure seamless integration of new processes into existing quality systems.



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