Senior Quality Assurance Specialist

12 hours ago

Navi Mumbai, Maharashtra, India beBeeQualityManagement Full time ₹ 12,00,000 - ₹ 30,00,000
Key Responsibilities:
  • Implement and maintain quality management systems for API manufacturing.
  • Lead audits, ensure timely closure of observations and CAPAs, and review validation protocols and batch records.
  • Oversee product release, stability studies, and quality documentation control.
  • Manage market complaints and implement corrective actions.
  • Ensure regulatory compliance with international guidelines.
  • Qualify vendors and suppliers 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 and international regulatory frameworks.
  • Proven experience with regulatory inspections.
  • Excellent leadership, documentation, and communication skills.

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