job details for:
Clinical Research - Clinical Quality Assurance Senior Auditor Jobs - Cambridgeshire

Clinical Research - Clinical Quality Assurance Senior Auditor Jobs - Cambridgeshire (Job Ref: WR/JOBS/25966-7108)

Job Description :

Flame Pharma - Clinical Research - Senior Clinical Quality Auditor Job - Cambridgeshire

An opportunity to work with one of the largest pharmaceutical services companies in the world has arisen for a talented and skilled Senior CQA Auditor. If you are looking for a challenge and to accelerate your career by working on multiple projects for world leading clients, then this position is for you.

Job Title

Senior Clinical Quality Auditor

Background

Due to expansion, our client are looking to recruit a Senior CQA Auditor to review and assess company activities to assure that contractual obligations to client companies are met, and that clinical trials are conducted and reported in accordance with ICH Guidelines.

Key Responsibilities

• Perform audits of study files, trial sites, and other audits as requested, to meet the requirements of audit plans.
• Perform compliance reviews of documents, including CQA review of ICFs.
• Provide CQA consultancy for selected clients and projects.
• Responsible for all project-related, contracted and internal CQA deliverables for projects from a range of clients.
• Takes responsibility, with minimal supervision from the QA Manager, for audit planning and project support.
• May be required by the CQA Regional Head to perform specific audits (e.g. database audit, clinical study report audits, facility, vendor or sub-contractor assessments).
• Participate in systems audits, leads non-complex process audits.
• Participate in client system audits (and leads preparation and hosting of these under supervision).
• Assists in training of CQA Auditor 1 staff during co-audits and co-reviews.

Qualifications and Experience

• Life Science degree or equivalent qualification and relevant experience.
• Detailed knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines.
• Experience of approx 40 - 50 site audits in a clinical research environment (can include auditing in GCP environment).
• Performed file and site audits to the standards required by CQA Management.
• Acted as lead auditor for file and site audits.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary from £30,000.

Key Words

Clinical quality Auditors , Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Cambridge.

For further information and to apply for this role, please contact Flame Pharma on 0800 085 0858.