CSV Lead – London – Competitive Package
I have an exciting opportunity for a Lead CSV expert to join an innovative cell and gene therapy organisation. You will have the opportunity to make a valuable contribution to the development of products which will transform and have the potential to save lives
Your mission is to authorise, execute, report and maintain validation lifecycle activities in compliance of cGMP and the QMS.
You will be responsible for
Leading validation activities and validation projects, ensuring compliance with quality and regulatory guidelines.
Execute and perform CSV data integrity assessments.
Act as the SME for all CSV related activities.
Generate and execute validation master plans.
Train junior members within the quality department on CSV requirements.
You will bring the following
Extensive CSV experience within a GMP highly regulated environment (minimum 5 years)
In depth working and theoretical knowledge on Data integrity
The ability to engage cross functionally with different departments in the business
Hands on working knowledge of IT / Lab Systems / ERP Systems
If this role is for you or someone that you know then then please get in touch by applying directly or reaching out to me on: