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| Job Location | Northumberland |
| Education | Not Mentioned |
| Salary | 50,000 - 55,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
CSV Specialist - Pharmaceutical - Permanent - North East, UKOur client is a leading pharmaceutical manufacturer. At present they are seeking a CSV Specialist on a permanent basis at their site in the North East, UK. As the CSV (Computer System Validation) Specialist you will report directly to the Head of Data Integrityand CSV/CSA Compliance and be the subject matter expert responsible for implementing Computer System Validation across the site.Responsibilities:Championing full lifecycle validation for all applicable computerised systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.Validating manufacturing, laboratory and other business systems.Working with project teams to compile user requirements for local and group software systems.Carrying out risk assessments and periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life.Using quality risk management to deliver scalable approaches to CSV.Authorising validation plan deliverables and CSV COPs / policies.Writing test plans / scripts and carrying out documented black box testing throughout systems lifecycles.Participating in Performance Qualification (PQ) and User Acceptance Testing (UAT) ensuring that the appropriate documentation of testing is performed.Working with system vendors to leverage appropriate information and documentation into CSV activities.Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.Keeping up to date with advances in the CSV field, regulatory requirements and good practice guidance.Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity.Participating in both internal and external audit inspections from a CSV perspective.Delivering compliant validated systems by design.Supporting system administrators and the Training & Development department in training employees on the correct use of computerised systems in line with procedures and regulations.Experience:Degree/post-graduate education or experience in Chemistry or life science subject.Previous experience of working in the life sciences industry (e.g. Pharmaceutical / Biotechnology) in Quality function.In depth knowledge of GAMP5 and a broad understanding of validation principles in general.Good knowledge of FDA / MHRA and other governing bodies regulations and requirements for GxP, data integrity and data governance.ISTQB testing qualification and or experience desirable.FDA 21 CFR Part 11, EU Annex 11 knowledge and application.