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    Global Gmp Expert Quality Auditor

    Novartis
    15+ years
    Not Disclosed
    India
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: GMP Audit Lead
    Company: Novartis Healthcare Private Limited
    Location: Mumbai (Head Office), India
    Division: Operations
    Business Unit: Innovative Medicines
    Functional Area: Quality
    Job Type: Full-time, Regular
    Shift Work: No

    Role Purpose

    The GMP Audit Lead is responsible for conducting independent GMP audits in compliance with the Novartis Quality System and current GMP regulations. The role involves assessing compliance with applicable regulations, standards, and guidance documents at various manufacturing sites, development centers, laboratories, warehouses, and suppliers. The position also provides expert consultation, contributes to strategic planning, and represents Novartis in external interactions with Health Authorities and industry groups.

    Key Responsibilities

    • Audit Strategy & Planning:

      • Contribute to establishing a global risk-based audit strategy and program.
      • Plan, lead, and conduct GMP audits, documenting and following up according to Novartis Quality procedures and applicable regulations.
      • Focus on complex, high-risk sites and activities, such as sterile manufacturing, biologics, combination products, etc.

    • Regulatory & Compliance Expertise:

      • Provide technical guidance and mentorship on audit activities.
      • Review and approve corrective action plans (CAPA) and ensure timely remediation.
      • Represent Novartis in regulatory hearings and external inspections.

    • Reporting & Documentation:

      • Prepare detailed audit reports in accordance with Novartis requirements and timelines.
      • Ensure appropriate escalation of critical findings and support immediate follow-up as per management requirements.

    • Training & Mentorship:

      • Mentor junior GMP staff and support GMP training programs.
      • Contribute to the auditor certification program by mentoring and assessing junior auditors.

    • Collaboration:

      • Work with internal stakeholders to ensure compliance and provide consultation for continuous improvement projects.
      • Support Health Authority commitments and global initiatives resulting from inspection findings.

    Experience & Qualifications

    • Education:

      • Degree in Chemistry, Pharmacy, Biology, Engineering, or a related science field (Advanced degree preferred).
      • Relevant experience may also be accepted.

    • Experience:

      • Minimum 15 years of experience in the Pharmaceutical or Medical Device industry.
      • At least 3+ years of auditing experience with deep knowledge of regulatory requirements.
      • Operational experience in QA/QC management, manufacturing, or regulatory health authority roles.
      • Expertise in areas like DP Manufacturing, Sterile, Biologics, Medical Devices, Microbiology, and Quality Systems.

    • Skills:

      • Excellent interpersonal, leadership, and facilitation skills.
      • Ability to independently manage and evaluate complex compliance issues.
      • Willingness to travel up to 60% of the time.

    Why Novartis?

    Novartis is committed to improving and extending people’s lives. Join us to contribute to this mission while collaborating with passionate colleagues to bring innovative medicines to patients.

    Commitment to Diversity & Inclusion

    Novartis fosters an inclusive work environment where diversity is celebrated. We are committed to creating a workforce that reflects the diverse communities we serve.

    Join the Novartis Network

    If this role doesn’t match your career goals, join the Novartis Network to stay informed about future opportunities: Novartis Talent Network.

    Benefits & Rewards

    Explore the benefits and rewards Novartis offers to help you thrive personally and professionally: Novartis Benefits & Rewards.

    Accessibility & Accommodation

    Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. Contact us at diversityandincl.india@novartis.com for assistance.

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