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Policy and Projects Specialist

1 month ago

Cambridge Cambridgeshire, United Kingdom Blackfield Associates Full time

Blackfield Associates are currently partnered with a Cell and Gene Therapy organisation in their search to find a CSV Specialist to join their team at their facility based in Cambridgeshire.

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

This role will primarily focus on validating the onboarding of new computerised systems to meet the needs of a rapidly growing customer base, as well as supporting the ongoing validation of expanding software systems. The position involves close collaboration with IT to establish data integrity requirements and evaluate the effectiveness of implemented solutions.

Support the implementation of a risk-based approach to the validation of computerised systems to ensure compliance with Annex 11, 15 and GAMP 5.
• Preparing and execution of protocols for configuration, functional, end-to-end and user acceptance testing.
• Preparing and maintaining validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for computerised systems projects.
• Sufficient prior experience of validating computer systems in a Biopharmaceutical setting.
• Experience in the validation of GxP software and Laboratory systems.
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