We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
• Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
• Keeps systems and processes developed for computer and automation systems validation up to date and compliant.
• Gives guidance on all activities related to computer and automation systems validation.
• Support activities include, but are not limited to, SOP creation, documentation review and approval
• Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
• Compiles and analyses validation data and makes recommendations for changes and/or improvements.
• As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
• Serves as an information resource for computer systems validation to validation engineers, contractors and vendors.
Education & Experience
• Bachelors degree in a technical, scientific or related field is preferred.
• Experience in CSV system development life cycle is required.
• Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
• Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480