CSV & DI Lead - S3 Science S3 Science

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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