API Manufacturing Quality Assurance Lead

2 days ago

Navi Mumbai, Maharashtra, India beBeeQuality Full time US$ 90,000 - US$ 1,20,000
Job Title

We are seeking a seasoned Quality Assurance Manager to oversee our API manufacturing unit's quality systems.

  • The ideal candidate will establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit.
  • They will lead and participate in regulatory, internal, and third-party audits; ensure timely closure of observations and CAPAs.
  • Review and approve validation protocols, master documents, and batch records in line with regulatory requirements.
  • Oversee product release, stability studies, and quality documentation control.
  • Manage and investigate market complaints and implement appropriate corrective actions.
  • Ensure regulatory compliance with international guidelines (e.g., USFDA, EU-GMP, WHO-GMP).
  • Handle vendor audits and qualification for raw materials, packaging materials, and third-party manufacturers.
  • Train and guide the QA team to ensure continuous improvement and inspection readiness.
Required Skills & Qualifications:
  • Bachelor's/Master's degree in Pharmacy, Chemistry, or a related field.
  • 8–12 years of experience in QA roles within API manufacturing, including managerial experience.
  • Strong understanding of GMP, ICH guidelines, and international regulatory frameworks.
  • Proven experience with regulatory inspections (USFDA, MHRA, EUGMP, etc.).
  • Excellent leadership, documentation, and communication skills.

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