Our Client a leading CRO is a full service clinical development organisation performing all aspects of clinical trials. They are a dynamic, proactive multicultural CRO, offering a high quality, customised and flexible service.
Due to continued success our client now has an exciting opportunity for a Senior Quality Assurance Manager to join their QA department.
The Quality Assurance Manager (QAM) will assist the head of
Quality Assurance with the implementation and maintenance of QA programs.
Scheduling and conducting audits both internally and externally. Producing reports following all audits and follow up resolutions.
Facility inspection of preferred vendors.
Successful candidate will have a Science / health degree with
a proven knowledge of GCP
And a proven track record in Quality Assurance experience within an ICH GCP environment or clinical research discipline either in CRO or pharmaceutical industry.
Proven track record as a GCP Auditor.
Must be experienced in conducting audits:
• Investigator sites
• Data management
• Clinical study reports
• Computer systems for 21 CFR Part 11 compliance
• Internal system audits
Awareness of GxPs relevant to the conduct of a clinical trial and the ability to multi-task.
You must have proficient use of computer skills.
Willingness to travel internationally and within the UK
Salary 35 – 40K Approx.
Location Thames Valley Berkshire.
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