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Job

Senior PV Auditor

  • Location

    Unknown

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Rob Steel

  • Contact email:

    r.steel@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    Senior PV Auditor

  • Published:

    24 days ago

  • Expiry date:

    2021-12-03

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a global biopharmaceutical company that is in in a big phase of growth that specializes in CNS, Nephrology and Oncology. Due to expansion, the company is looking

The role is a part of a dynamic team performing global pharmacovigilance risk assessments, managing and performing pharmacovigilance audits, including pre- and post-audit activities such as authoring audit reports and/or reviewing audit reports.

Please see a summary:

  • Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
  • Plan, supervise, conduct, and support internal and external GxP audits
  • Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
  • Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
  • Support the preparation for GxP inspections
  • Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution

 

This is a great opportunity for someone with PV QA experience to step up into a Senior PV Auditor role.