Job Title: Expert GMP Auditor
Job ID: REQ-10005048
Date Posted: Dec 03, 2024
Location: Mumbai, India
Division: Operations
Business Unit: Innovative Medicines
Company / Legal Entity: IN10 Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time (Regular)
Shift Work: No
Summary
Lead, support, and report independent GMP audits according to the Novartis Quality System and current GMP regulations to assess compliance with applicable laws, standards, and guidelines. This includes internal and external audits of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
Provide expert consultation through risk-based assessments, review and approve CAPAs, and represent Novartis with Health Authorities and industry groups. Act as SME in one or more manufacturing areas and support strategic alignment with senior leaders.
Key Responsibilities
Contribute to establishing the strategic direction of a global risk-based audit strategy and program.
Plan, lead, conduct, document, and follow up GMP audits per Novartis Quality procedures and applicable regulations/standards.
Audit complex, high-risk sites and activities as an SME (e.g., sterile manufacturing, combination products, biologics).
Provide technical guidance, mentoring, and training on audit activities.
Review and approve corrective action plans (CAPAs) for audit findings.
Escalate critical findings to responsible management and support immediate follow-up measures.
Prepare and submit audit reports within required timelines.
Provide regulatory guidance for timely remediation and recommendations on filing acceptability.
Act as GMP compliance consultant for trainings, task forces, and continuous improvement initiatives.
Review and advise on relevant policies and procedures.
Mentor junior GMP staff and train non-certified/junior auditors.
Maintain up-to-date expert knowledge of GMP regulations; contribute to auditing best practices.
Support Health Authority (HA) commitments and global initiatives arising from inspection findings.
Essential Requirements
Experience:
Minimum 15 years in Pharmaceutical/Medical Device industry (QA/QC, manufacturing, development, or regulatory authority).
At least 3+ years of direct auditing experience.
Broad operational expertise with excellent regulatory knowledge.
Technical Expertise (at least one):
Drug Product (DP) Manufacturing
Laboratories activities
Medical Devices
APIs & Excipients
Sterile Manufacturing
Biologics
Microbiology
Computer System Validation
Packaging activities
Quality Systems
Skills:
Strong interpersonal, leadership, and facilitation skills.
Diplomacy, persuasion, and ability to represent Novartis internally/externally.
Sound judgment in interpreting and applying GMP regulations.
Ability to independently manage and evaluate complex compliance issues.
Other:
Willingness to travel ~60% of the time.
Experience interacting with Health Authorities (local and international).
Desirable Requirements
Degree in Chemistry, Pharmacy, Biology, Engineering, or related science.
Excellent oral and written English communication skills.
Additional language proficiency preferred (e.g., German, French, Italian, Chinese, Spanish).
Why Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives, aiming to become the most valued and trusted medicines company in the world. Join our diverse, inclusive, and collaborative team, where your expertise contributes directly to breakthrough innovation.
📖 Learn more about benefits and rewards: Novartis Life Handbook
🌍 Join our Novartis Talent Network: Sign up here
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