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Head of Quality Assurance

One of the Pharma MNC

AhmedabadFull-timeMid LevelOn-site

Job Description

Key Responsibilities:


#Must have exposure of Sterile (Injectable)


Lead the overall Quality function including:

  • Quality Assurance (QA)
  • Quality Control (QC)
  • Microbiology
  • Ensure compliance with global regulatory requirements such as EU GMP, MHRA, TGA, PIC/S, ANVISA, and cGMP.
  • Develop, implement, and continuously improve the Quality Management System (QMS).
  • Lead and manage regulatory inspections and customer audits.


Oversee:

  • Batch Release
  • Validation
  • Deviation Management
  • CAPA
  • Change Control
  • Documentation & Data Integrity
  • Stability Program
  • Ensure compliance with GMP and quality standards for sterile injectable manufacturing.
  • Build a strong quality culture across the organization.
  • Collaborate with Production, Engineering, R&D, Regulatory Affairs, Supply Chain and other cross-functional teams.
  • Mentor, develop and lead a large Quality team.


#QualityHead #QAQC #QualityAssurance #SiteQuality

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