Cvs & di Lead

3 weeks ago

London, United Kingdom S3 Science Full time

CVS & DI Lead

Permanent

£62,000 - £75,000

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
- 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

**Job Types**: Full-time, Permanent

**Salary**: £62,000.00-£75,000.00 per year

Schedule:

- 8 hour shift
- Monday to Friday
- Overtime
- Weekend availability

Ability to commute/relocate:

- London: reliably commute or plan to relocate before starting work (required)

Work Location: One location

Reference ID: HS/CVS

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