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    Job · 15065053

    Apotex Research Pvt. Ltd logo

    Deputy General Manager Quality Assurance - Audit and Compliance

    Apotex Research Pvt. Ltd · Bengaluru · onsite · Posted 51d ago

    Undisclosed17–20 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role


    Role & responsibilities

    Quality Assurance - Audit Compliance and Risk Management

    • Experience 16+ years of experience in Pharmaceutical Quality, Compliance, Regulatory Affairs, Risk Management, or Quality Systems.
    • Strong knowledge of FDA, Health Canada, EU GMP, MHRA, WHO, and other global regulatory requirements.
    • Experience in manufacturing, quality operations, inspection management, and Data Integrity programs.
    • Demonstrated leadership experience in regulated pharmaceutical environments.
    • Audit Compliance & Risk Management is responsible for leading the organization's pharmaceutical compliance, regulatory governance, risk management, data integrity, and inspection readiness programs. The role ensures compliance with global health authority regulations, GxP requirements, corporate quality standards, and patient safety expectations while fostering a culture of quality and continuous improvement.

    1. Compliance Management & Regulatory Oversight

    2. Enterprise Risk Management

    3. Data Integrity Governance

    4. Regulatory Inspection Readiness

    5. Quality Systems Governance

    6. Investigation & CAPA Oversight

    7. Supplier & Third-Party Compliance

    8. Training & Compliance Culture

    • Professional certifications such as ASQ, RQAP, Six Sigma, ISO Lead Auditor, Compliance Certifications, or Risk Management Certifications are desirable.

    Preferred candidate profile

    Core Competency expected in Pharmaceutical Compliance, Regulatory Governance, Enterprise Risk Management, Data Integrity (ALCOA+) , Quality Management Systems, GMP/GDP/GLP/GxP Compliance, Regulatory Inspection Management, CAPA & Investigation Excellence, Supplier Compliance, Quality Culture Development, Strategic Leadership, Stakeholder Management.


    Sourced from naukri

    Skills

    data integrityAudit ComplianceRegulatory Auditsrisk complianceGovernanceCAPAQuality ComplianceInvestigationInternal Auditquality governanceQuality AssuranceRegulatory ComplianceRisk Management

    About Apotex Research

    Apotex Research Pvt. Ltd logo

    Apotex Research Pvt. Ltd

    Pharma

    1.2k+

    employees

    2003

    23 years old

    Bangalore / Bengaluru, Karnataka

    India

    ₹9L PA avg

    Avg at Apotex Research

    About

    We improve everyday access to affordable, innovative medicines and health products for patients and consumers worldwide.

    Industries

    PharmaAnalytics & KPO

    Employee ratings

    10 reviews

    3.8/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    3.7

    Employees rate it well for

    Work-Life Balance38Overall Company38

    Find them on

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    Deputy General Manager Quality Assurance - Audit and Compliance · waiting for your command