Instagram
youtube
Facebook

Expert Gmp Auditor

15+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: BE/BSC/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

Here’s a concise, rewritten version of your text while retaining all key details:


Expert GMP Auditor – Mumbai

Role Summary:
Lead, support, and report on independent GMP audits in alignment with the Novartis Quality System and current GMP regulations. Assess compliance with regulations, standards, and guidance documents. Review and approve corrective action plans addressing audit findings. Audits span manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.

Key Responsibilities:

  • Develop and implement a strategic, global, risk-based audit program.
  • Plan, conduct, document, and follow up on GMP audits per Novartis Quality procedures and applicable standards.
  • Audit high-risk and complex sites, acting as an SME in areas like sterile manufacturing, biologics, and combination products.
  • Provide regulatory guidance and approve CAPA plans for timely remediation of findings.
  • Prepare comprehensive audit reports, escalate critical findings, and ensure timely follow-ups.
  • Offer consultation on GMP compliance, risk assessments, policies, and procedures.
  • Mentor and train junior GMP staff and auditors.
  • Represent Novartis in external interactions with health authorities and industry groups.
  • Maintain expert knowledge of regulations and contribute to best practices in auditing.

Essential Requirements:

  • 15+ years in the Pharmaceutical or Medical Device Industry, including QA/QC management, manufacturing, or regulatory roles.
  • 3+ years of auditing experience with strong regulatory knowledge.
  • Willingness to travel ~60%.
  • Expertise in areas such as DP manufacturing, sterile products, biologics, or quality systems.
  • Interaction with health authorities and experience in resolving regulatory issues.
  • Strong interpersonal, leadership, and facilitation skills.

Desirable Requirements:

  • Degree in Chemistry, Pharmacy, Biology, Engineering, or related sciences.
  • Proficiency in English; additional languages like German, French, or Spanish are preferred.

Why Join Novartis?
Be part of our mission to reimagine medicine and improve lives. Novartis fosters a collaborative and inclusive work environment that values its people. Learn more about our strategy and culture here.

Benefits and Rewards:
Explore our benefits and rewards in the Novartis Life Handbook.

Join the Novartis Network:
Connect with us to explore career opportunities or join our talent community here.

Division: Operations
Business Unit: Innovative Medicines
Location: Mumbai, India
Employment Type: Full-Time, Regular
Accessibility: Novartis supports individuals with disabilities and provides reasonable accommodations as needed. For assistance, email: diversityandincl.india@novartis.com.


Let me know if you’d like any further refinements!