Hobson Prior currently have an exciting opportunity for a GCP Principle Auditor to join one of the world's largest contract research organisations in Europe, who support human clinical trials develop new life saving drugs. This position will report into the QA Manager and will provide day-to-day support to the quality assurance function. This role can be office or home based.

Job Responsibilities:

• Accountable to set up the annual quality audit programme.
• Conduct reporting and follow-up of quality system, computer system validation and service provider audits.
• Ensure the quality audit programme is followed and kept up to date.
• Ensure audit results are formally recorded and reported and that corrective/preventative actions are documented.
• Maintain the approved service provider list.
• Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA.
• Production of the annual trend analysis using QA metrics.
• Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits.
• Where needed, produce training documentation relating to quality and regulatory areas for both QA and the organisation.
• Partake in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans).

Key Skills:

• Demonstrates leadership ability, communication, and facilitation skills.
• Be able to work on own initiative and able to function independently or as part of a team.
• Self-motivated.

Requirements:

• You will have GCP and CSV QA experience.
• Prior experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies.
• Prior experience in the management of documents (Policies, SOPs etc.).
• Expert knowledge of GCP and applicable regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.