Due to continued growth, Clintec is recruiting an Associate Quality Specialist to join our HQ team in Glasgow.
Clintec is actively recruiting for an Associate Quality Specialist to join our expanding global company in our Glasgow Headquarters. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits
The Associate Quality Specialist will contribute to the development, implementation and coordination of clinical trial quality and to prevent or eliminate GCP infringements. The successful candidate will represent the QA department of the company by participating in Clintec International’s QA activities.
Actively manage the implementation and maintenance of the Clintec Quality Management System
Co-ordinate the review, implementation and change control of SOPs and working documents to all functions in Clintec International to ensure compliance with ICH GCP and country specific regulatory requirements
Produce and review quality documents as required
Ensure departments have current knowledge of ICH GCP, clinical regulatory requirements and relevant SOPs including development of training materials
Support in the conduct of audits as defined in the Audit Plan and timely follow up on corrective and preventative action (CAPA)
Maintain database / trackers (as appropriate) for quality analysis, assessment and compliance risk
Assist in the preparation and participation of Client audits and regulatory inspections
Assist in promoting and advancing quality awareness throughout Clintec
Provide support to the QA team as required
A minimum of 1 year experience in a similar role
Solid GCP knowledge is essential
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.