Job Description
BioTalent has teamed up with a CRO focussed on providing clinical research services who are on their search for a QA CSV Specialist/Manager . You will be responsible computer system validation activities, ensuring compliance with FDA, EMA, GAMP 5, and internal policies. This is a Remote position, however you must be based in either The United Kingdom, The Netherlands, or Belgium . You will be responsible for: Providing expert guidance on Good Clinical Practice to ensure quality, data integrity, and safety across all our services Reviewing lifecycle validation documentation and system changes Drive validation project completion, support computerised systems investigations, and participate in internal and external audits Management of qualification, changes, and deviations across systems using advanced Quality Management Systems such as Veeva, MasterControl, and Trackwise You will bring the following: A degree in Life Sciences, Engineering, or Computer Science Experience in a QA position, specialising in CSV / IT Solid experience in a GxP environment Experience working with QMS e.g. Veeva, TrackWise, MasterControl