Focused Recruitment are currently working alongside our client who are a global leader in supply chain services and pharmaceutical packaging. We are Recruiting for a Computerized Systems Validation (CSV) Specialist out of their 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 & Responsibilities will include:- 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
Desired criteria for the role:- 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
By applying for this position you are giving authorisation for Focused Recruitment Ltd to contact you regarding this vacancy and other vacancies we feel may be suitable for you. We will not present your CV to any clients without your explicit consent. We will contact you if your CV is of interest, if you are unavailable we will leave a message, YOU MUST return this call otherwise your application cannot progress any further.Focused Recruitment are a multi award winning independent recruitment agency covering South Wales and the South West. As a service driven company we are fully committed to working with clients and candidates that share this value. We consistently place the right people, into the right companies, with the right roles to fulfil their career aspirations.
