Computer Systems Validation Officer (CSV) in Suffolk

Validation Officer (Computerised Systems)

Location: Haverhill, Suffolk (£45-£50p/h with up to 60 for the right candidate)

You would be working at a pharmaceutical manufacturing company, responsible for computer system qualification and validation activities in accordance with corporate standards, site procedures, User requirements, equipment specifications and regulatory guidelines thereby maintaining cGMP for the site.


-to undertake validation duties assigned by the senior quality manager or QA CSV specialist
-provide support and guidance to site projects, operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV
-to prepare, execute and report validation documentation with respect to CSV
-review and approve validation deliverables and provide guidance in their creation
-drive continuous improvement
-support in the review and approval process for periodic and security reviews to support adherence to their schedules
-supports maintenance of local computer system inventory
-keeps up to date on regulations and legislation with respect to CSV
-provides support during internal and third party audits
-may supervise other staff and contractors when required
-ensure all corrective and preventative actions in their value stream are completed within the agreed timeline


-specialist knowledge of CSV within the pharma/biotech industry
-understanding of the regulatory expectations relating to CSV
-understanding of validation principles and the GMP expectations as applicable
-in depth knowledge of GAMP
-an understanding of data integrity in line with recent regulatory expectation
-experience of CSV in a pharmaceutical manufacturing environment
-working experience with equipment control systems, IT systems and lab systems/automation systems
-BSc in Scientific, Engineering, IT discipline or similar/equivalent experience






Daily Rate

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