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Quality Manager - CSV Auditor

Quality Manager - CSV Auditor

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    28359_1648807674

  • Published:

    about 2 months ago

  • Expiry date:

    2022-05-01

  • Consultant:

    #

Job title: Quality Manager - CSV Auditor

The main purpose of this role is the development and execution of the Global CSV Audit Strategy and Global CSV Audit Plan in close collaboration with the CSV Audit Lead and the Associate Director CSV Audit. This includes defining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach.

Responsibilities:

  • Develop, maintain and provide input to the Global CSV audit plan
  • Manage audits and contract auditors in line with the Global CSV audit plan, internal business model and applicable procedures
  • Plan, supervise, conduct and support internal and external GxP related CSV audits
  • Follow up on the development, implementation and completion of CAPAs
  • Ensure continuous improvement of internal Quality Management System
  • Coordinate/support the preparation for GxP inspections
  • Coordinate/support responses to Regulatory Authorities

Requirements:

  • Degree in Natural Science or equivalent business experience in a field related to the scope of audits performed
  • Experience as a lead auditor on internal audits and external vendor audits
  • Several years of Information Technology (IT) industry / pharmaceutical industry / medical devices industry / Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, Computerised System Validation and Data Integrity
  • Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and / or development

Salary and benefits:

A highly competitive salary, annual bonus and wider benefits package is on offer with this role

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk