- 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.
- 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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Quality Assurance Manager(API) - Navi Mumbai, Thane - confidential
Description
Key Responsibilities:
Required Skills & Qualifications:
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Assurance Manager
Only for registered members Mumbai, MH, IN,
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Quality Assurance Manager
Only for registered members PAN India
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Analytical Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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