An international contract research organisation (CRO) is recruiting for a QA Specialist to join their Sussex-based team. The company provides complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases and conducts studies which lead to marketing approval of significant medical advances. This is an exciting opportunity to work with a firm that has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfils all regulatory requirements.
- Maintaining Quality Management system, including incident and CAPA management, 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).
- Advising on the design, implementation, and improvement of GCP and GMP compliant clinical trial systems, processes, and procedures.
- Managing the review, preparation, and distribution of Oncology SOPs.
- Maintaining an awareness of regulations and guidelines relating to the conduct of all aspects of clinical trial activities produced by world-wide Regulatory Agencies and providing recommendations as to how these are to be implemented by Oncology in Europe and, where appropriate, the USA.
- Liaising with Sponsors and Regulatory Agencies in the co-ordination of audit or inspection visits, as necessary.
- Assisting with delivery of Audit Program.
- Providing training to (Europe) Ltd personnel, when appropriate.
- Performing the duties assigned to Quality Assurance by the Oncology SOPs.
Skills and Requirements:
- Bachelor's degree required.
- 2+ years of relevant QA experience within clinical research required.
- GCP & Clinical Research legislation knowledge required.
- 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.
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.
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