Computer Systems Validation Engineer
In partnership with its client CPL is currently seeking for a CSV Engineer for a FTC role in the Limerick area.
1 year Fixed Term Contract
Responsibilities:
Co-ordination, implementation and active participation in the validation programme for all business computer systems.
· Conduct validation activities in compliance with US and EU regulations, and global corporate procedures.
· Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
· Develop validation documentation as required
· Review and approve documents prepared by the validation team, other functional departments and contractors.
· Execute qualification protocols as required
· Prioritize qualification activities in line with the project schedules and business needs.
· Prepare reports of executed protocols
· Resolve and assist in the closure of deviations initiated during qualification execution
· Initiate and implement change control activities.
· Co-ordinate re-validation activities
· Generate SOP's / other documentation as applicable
· Conduct training in validation methodologies and related procedures as required.
· Present validation systems at internal and external audits
· Support quality assurance programmes
Requirements:
· Relevant 3rd Level Qualification in science or engineering.
· A minimum of 5 years IT validation experience in an established QA function in the pharma industry.
· Strong knowledge of CSV/GAMP, 21CFR Part 11, Project Life Cycle and GMP Regulations.
· Validation experience of GAMP 5 systems would be an advantage
· Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills.
· Adaptable and flexible.
CPL Contact:
To apply or for further information please contact Julio Garcia on +353 1 6146121 begin_of_the_skype_highlighting +353 1 6146121 end_of_the_skype_highlighting begin_of_the_skype_highlighting +353 1 6146121 end_of_the_skype_highlighting or e-mail with you updated CV to julio.garcia@cpl.ie
Keywords: Validation Engineer, Computer Systems Validation, CSV, Validation Specialist, 21 CFR part 11, GAMP 5, Life cycle, QA Validation, Limerick, Ireland.