Kerr Dental

Senior Global GCP/PV Auditor

Kerr Dental

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇪🇸 Spain

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GCPPVGxP regulationscomputer systems validation21CFR Part 11audit strategycorrective action plansregulatory compliance auditsquality systemrisk-based audit
Soft skills
independent managementobjective evaluationtask prioritizationoversightstrategic developmentcollaborationcommunicationreportingproblem-solvingadaptability
Certifications
auditor certification