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. This role requires 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.
* Setting up, implementing and securing validation studies, in consultation with employees of the IT department, Operations, Supply Chain, Technical Service, QA and engineering.
* Documenting all validation activities and results specifically relating to CSV.
* Contributing to the improvement and optimization of personnel, processes and systems and procedures.
* Assessing the required validation in response to proposed changes in systems, processes, installations or equipment relating to CSV.
* Supporting and/or conducting internal audits at both locations to improve the quality level.
* Acting as SME during external audits in the field of CSV.
Competencies:
* Driven personality
* Ownership (sense of responsibility)
* Ability to organize work independently and set the right priorities, as well as work in a team.
* Deliberate
* Analytical and open-minded thinking skills
* Ability to travel to Netherlands or Belgium for short periods
Preferred Qualifications:
* 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.
* Proficient with MS Office.
* Good knowledge of English and Dutch (written and spoken).
* Experience in writing reports.
If you are interested in this role, please apply!
CPNewport
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