Computerized Systems Validation Specialist

Job Title: Computerized Systems Validation (CSV) Specialist Location: Rhymney (this can be home based) Salary: £45-55k Per annum Hours: Full time. Monday – Friday days regular. Here at The Recruitment Co, we are recruiting a Computerized Systems Validation (CSV) Specialist to work for a company based in Rhymney although you can work from home. are engineered to deliver. We are pleased to be hiring a Computerized Systems Validation (CSV) Specialist out of our UK site based in Rhymney, Wales. This role is open to onsite, hybrid or home working. But there is a requirement for regular travel between the UK and our EU sites in Belgium and Netherlands. The role is to ensure that all IT systems that impact GMP are in a validated state. Reporting to the Quality Manager in EU. Duties and Responsibilities: Keeping an overview of all IT systems and the extent to which they have undergone CSV; manage and monitor this validation status so that all software and hardware adjustments, changes and updates are also subject to CSV. Keeping the Computerized System Validation Master Plan and all validation related procedures up to date. Keeping the overview of GMP critical Computer Systems and their validation status up to date. Drawing up specific validation documents for GMP Computerized Systems, such as risk assessments, regulatory assessments, test protocols and reports, etc. Setting up, implementing and securing validation studies, in consultation with employees of the IT department, but possibly also Operations, Supply Chain, Technical Service, QA and engineering. Documenting all validation activities and validation results and more specifically those relating to CSV. Contributing to the improvement and optimization of personnel, processes and systems and procedures carried out. Assessing the required validation in response to (proposed) changes in systems, processes, installations or equipment and more specifically those relating to CSV.systems/artwork management en control systems, Supporting and/or conducting internal audits at both locations to improve the quality level SME during external audits in the field of CSV Competencies: Driven personality Ownership (sense of responsibility) Can organize work independently and set the right priorities, as well as work in a team. Deliberate Analytical and open-minded thinking skills Can travel to =Netherlands or Belgium for short periods Preferred Preferably Master or Bachelor in IT, minimum HBO working and thinking level Several years of experience in a pharmaceutical production environment is a plus. Experience with setting up and supervising CSV or other validation studies is a plus. Familiar with GMP guidelines, pharmaceutical guidelines, hygiene, etc. Knowledge of GAMP5 Experience with quality systems, procedures, training, etc. Can work with MS-office Good knowledge of English and Dutch (written and spoken) Experience in writing reports If you are interested in this role then please apply! CPNewport TPBN1_UKTJ