Quality Assurance Manager(API)

Key Responsibilities:

• Establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit.
• 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.