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

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