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Quality Assurance Executive To Manager

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Vadodara, Gujarat, India Ami Lifesciences Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Ensure compliance with cGMP, regulatory, and internal quality standards.
  • Manage QMS activities deviations, change controls, CAPA, OOS/OOT, document control, etc.
  • Handle Analytical Quality Assurance (AQA) activities data review, audit readiness, and compliance monitoring.
  • Oversee In-process Quality Assurance (IPQA) – batch manufacturing records review, shop floor monitoring, line clearance, process compliance.
  • Conduct internal audits, support external audits (regulatory and customer), and ensure timely closure of audit observations.
  • Drive new initiatives in digitalization, automation, and process improvement in QA systems.
  • Training and mentoring of team members to strengthen quality culture.

Preferred candidate profile

  • B.Pharm / M.Pharm / M.Sc. (Chemistry) with 4 – 15 years' experience in QA in API Pharma industry.
  • Strong knowledge of AQA, QMS, IPQA, documentation, and regulatory compliance.
  • Hands-on experience in handling audits (USFDA, EU, WHO, etc.).