QA Lead

1 day ago

Ankleshwar, Gujarat, India beBeeQuality Full time ₹ 12,00,000 - ₹ 15,00,000

Lead Quality Assurance Specialist

A highly experienced QA professional is sought to lead deviation and complaint investigations, along with core QMS activities in a regulatory-approved manufacturing environment.

About the Role

  • Manage the implementation of corrective actions from deviations, complaints, review batch records, APQR, and SOPs.
  • Ensure effective execution of change controls, validations, qualifications, and QMS documentation.
  • Conduct regulatory gap assessments and support compliance plan execution.
  • Coordinate GMP training, documentation control, and audit readiness.

Key Requirements

  • 3-6 years of QA experience in pharmaceutical formulations.
  • Strong understanding of cGMP, investigation tools, and regulatory expectations.
  • Skill in QMS systems.
  • Excellent analytical, coordination, and documentation skills.

Responsibilities

  • Deviation and complaint investigations with timely CAPA execution.
  • Implementation and tracking of CAPAs from deviations, complaints, review batch records, APQR, and SOPs.
  • Change controls, validations, qualifications, and QMS documentation management.
  • Regulatory gap assessments and compliance plan execution.
  • GMP training, documentation control, and audit readiness coordination.

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