Senior Manager, CSV Auditor

1 month ago

Eastern England, United Kingdom Practicus Full time

Senior Manager, CSV Auditor (Global Quality Management)

Permanent, Full time (Paying up to £78,157 + benefits)

Hybrid working - ad hoc travel required to their office near London (about once a month) and 30% travel to supplier sites across the globe.


Our client, a global pharmaceutical company is seeking a CSV Auditor (Senior Manager, within the Global Quality Management team) to manage and perform audits with focus on Computer System Validation (CSV).


You will be supporting the development, implementation, continuous improvement and documentation of their Companies’ Quality System. Additionally, you will develop, maintain and provide input to an adequate audit plan for global, regional and local, computerised systems and compliance processes.


The successful candidate will provide sound advice and interpretations related to current GxP guidelines and regulations on CSV & Data Integrity to Senior Management and their employees.


Knowledge and Experience:

  • Degree in natural science or equivalent business experience.
  • 7+ years of pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data Integrity.
  • Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance.
  • Experience as a Lead Auditor on internal audits and external vendor audits.
  • Experienced in GxP related CSV audits and inspections.
  • Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development
  • Understanding of computer hardware and network/infrastructure requirements


About you:

  • Excellent leadership skills and knowledge of working in a cross-cultural business environment
  • Well versed with MS Office
  • Very good communication skills (written and oral) in English
  • Problem solving and resolution skills
  • Analytical and creative thinking

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