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!

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