Quality Assurance Manager(API)

2 weeks ago

Thane Navi Mumbai, India Acme Services Full time

Job Description 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. - 812 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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