CSV Lead

Posted 31 August 2022
LocationLondon
Job type Permanent
DisciplineEngineering & CQV
Reference65777
Contact NameSarah Ghaziri

Job description

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:

sarah.ghaziri@biotalent.com

 +443333076137