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You will be working as part of the Global R&D audit team who has remit for the GCP PV and GLP audit programme. The team consists of a group of engaging, motivated and highly respected experts in GxPs, with many years of industry, research and regulatory agency experience.  You would work with expert auditors across global locations as well as with multi-disciplined audit teams. The position reports to the GCP Audit Manager.

The Role:

It is a key position in the Quality Assurance (QA) group, with primary responsibility for planning and participating in global GCP audits.  The breadth of audits performed include audits of clinical trials, vendors, internal process and there is also opportunity to audit pharmacovigilance activities.

Responsibilities:

Key responsibilities include: 
• Plan, conduct and report routine and directed clinical trial and/or PV compliance audits
• Follow-up on corrective actions until resolution
• Identify and communicate compliance risks to QA and R&D management
• Host and/or play a role in regulatory authority inspections
• Contribute to or lead QA process improvement initiatives

• Author and contribute to the development of QA cross functional controlled documents

Basic qualifications:

  • Bachelor’s degree in a scientific discipline.
  • Extensive auditing experience in GCP.

 

Preferred Qualifications:

  • Postgraduate qualification.
  • PV auditing experience.
  • Experience supporting regulatory authority inspections.
  • International auditing experience.
  • Participation in process improvement initiatives.

Location:

Cambridge or Uxbridge

Remuneration:

Competitive salary & comprehensive benefits package including bonus scheme

To learn more about this role, please apply or contact Paul directly on paul.shaw@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Paul Shaw direct on to discuss this and other vacancies that may suit.

Paul Shaw

Email: paul.shaw@bluepelican.com