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Details

QA CSV Engineer


Reference:SMC0037111 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, QA Analyst

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.

Duties

• 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