Principal QA Auditor

A functional biometrics organisation is seeking to recruit a Principal QA Auditor to their office in Thetford. The company specialises in clinical data management, optimal process design, and statistical expertise. This is an exciting opportunity to work with a leading organisation that works with global pharma, biotech, and medical device partners around the world.

Job Responsibilities:

• Set up the annual quality audit programme.
• Ensure the quality audit programme is followed and kept up to date.
• Conduct reporting and follow-up of quality system, computer system validation and service provider audits.
• 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.
• Where required, produce training documentation relating to quality and regulatory areas for both QA and SQN. Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans).
• Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits.

Skills and Requirements:

• GCP and CSV QA experience.
• Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies.
• Experience in the management of documents (Policies, SOPs etc.).
• Expert knowledge of GCP and applicable regulations.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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