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Permanent Positions

CSV & DI Lead
London, London

CVS & DI Lead

Permanent

£62,000 – £75,00

 

We have an amazing opportunity for a CVS & DI Lead to join our clients state of the art manufacturing facility in central London.

 

Our client is a clinical stage gene therapy company who focus on developing treatments for patients living with serious diseases, specifically diseases of the eye, salivary gland and central nervous system.

 

Purpose of Job

  • Support the business with the implementation, development and management of compliance related electronic systems, leading validation activities for the identification, and installation of compliance related computer systems
  • Support supplier assessments for systems and internal audits of processes utilising computerised systems
  • Provide training for the development of computer related compliance systems
  • Ensuring system reviews are performed and upgrades are managed

 

Major Activities

  • Ensure implementation of computer systems are planned, tracked and achieved in accordance with timelines and in compliance with GxP requiremetns
  • Lead validation activities, ensuring that resources are managed appropriately
  • Liaise with the QA Supplier Assurance team to support internal and supplier software audits
  • Assure training and support to users
  • Ensure data integrity requirements are maintained in the use and application of compliance related computer systems
  • Assist in external audits for the qualification and management of IT and CSV suppliers

 

Key Performance Indicators

  • Validation Projects are implemented according to project timelines and GxP requirements
  • Validation Projects are appropriately resourced to support delivery to project timelines
  • Relevant systems are maintained in a validated state and are fit-for-purpose from an end user perspective

 

People Responsibilities

  • Manage and lead the QA IT & CSV team and all aspects of the people process including hiring, on-boarding, mentoring, annual, performance management and development
  • Responsible for ensuring that all work complies with GMP, Data Integrity and GDP and is undertaken in accordance with applicable procedures
  • Responsible for ensuring that any GMP documentation e.g. Issues, CAPAs, Change Controls, BMRs & audit/inspection actions

 

Job Background

  • Educated to degree level in Human Health, Sciences or equivalent
  • 5 years experience working in a GxP environment with focus on IT compliance and CSV
  • IT literate, experience implementing, managing and operating IT systems, particulary eQMS
  • Knowledge of GxP regulations and guidelines with regards to computer system validation and operation

 

 

Salary: £62,000 - £75,000
Date Posted: 19/10/2022
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