Senior Global GCP/PV Auditor
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Job Description
Lead GCP/PV audits according to NVS Quality System regulations while ensuring compliance with applicable standards. Review corrective actions and support audit strategy development with significant independence.
Responsibilities:
- Lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents.
- Review and approve corrective action plans in support of the audit observations, ensuring alignment with strategic direction of the company.
- Assist in driving implementation of the applicable actions.
- Travel up to 60% of time.
- Support the strategic development of an effective global risk-based audit strategy and programme.
- Collect, collate and incorporate input into audit strategy and plan.
- Conduct, document and follow-up of global quality regulatory compliance audits and assessments of GPvP according to specified requirements.
Requirements:
- Education: degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).
- Advance degree desirable.
- 7+ years of GCP and PV/Pharmaceutical Industry/Health Authority experience or equivalent up of which 3 years of GCP or PV auditing experience (or both).
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
- Ability to address a variety of tasks within the same timeframe while maintaining oversight.
- Extensive knowledge of applicable GCP/PV and GxP regulations, guidelines, policies and procedures.
- Good knowledge of computer systems validation and 21CFR Part 11 requirements.
- Auditor certification would be highly valued.
Benefits:
- You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
- Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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