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Senior Global GCP/PV Auditor

AuditorAuditorFull TimeRemoteSeniorTeam 1,001-5,000Since 1891H1B No SponsorCompany SiteLinkedIn

Location

Spain

Posted

172 days ago

Salary

0

Seniority

Senior

Bachelor Degree7 yrs expExperience acceptedEnglishGCP

Job Description

Senior Global GCP/PV Auditor

Kerr Dental

• 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.

Job 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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