Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents
Job Summary
Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
The Global GMP Senior Quality Auditor also ensures alignment with strategic direction of the company and assist in driving implementation of the applicable actions and provides consultation to Novartis business units through risk based assessments.
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Matching Summary
Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
Skills & Requirements
Must-have
Lead independent GMP audits
Assess compliance with regulations
Review corrective action plans
Risk-based audit strategy
Technical guidance and mentoring
Fluent English written and spoken
Nice-to-have
Interaction with local Health Authority
Other languages are a plus
Diplomacy and persuasion skills
Key Requirements
12+ years experience in Pharmaceutical or Medical Device Industry
3 years auditing experience preferred
Strong knowledge of GMP regulations
Solid operational experience
Strong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy