Quality Assurance Manager(API) - Navi Mumbai, Thane - confidential

    confidential
    confidential Navi Mumbai, Thane

    20 hours ago

    Full time ₹600,000 - ₹1,500,000 (INR) per year *
    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.
    • 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.
    * This salary range is an estimation made by beBee
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