My Client, a CRO based in West Sussex is seeking a QA Manager (GCP) on a permanent basis.
Salary: 40-45k
Location: West Sussex
JOB SUMMARY:
Implement a comprehensive and effective compliance auditing programme to provide assurance that clinical trial projects, and the systems and processes used in their conduct, comply with appropriate Good Clinical Practice (GCP) regulations, Good Manufacturing Practice (GMP) regulations and Standard Operating Procedures (SOPs).
Provide advice on the design, implementation and improvement of GCP compliant clinical trial systems, processes and procedures.
Manage the review, preparation and distribution of SOPs, through the SOP Committee.
Undertake the duties of Working Practice Document Co-ordinator.
Maintain an awareness of regulations and guidelines relating to the conduct of all aspects of clinical trial activities produced by worldwide Regulatory Agencies, and provide recommendations as to how these are to be implemented in Europe and, where appropriate, the USA.
Liaise with Sponsors and Regulatory Agencies in the co-ordination of audit or inspection visits, as necessary.
Provide training to personnel, when appropriate.
Perform the duties assigned to Quality Assurance by the SOPs.
SKILLS/BACKGROUND REQUIRED:
5+ years of relevant pharmaceutical experience auditing clinical trials (GCP) is preferred although transferable skills and experience obtained in the GMP or GLP setting are considered acceptable.
