Senior QA Validation Engineer Job in Limerick, Limerick Ireland

Co-ordination, implementation and active participation in the validation programme for all business computer systems. Lead small team of computer validation specialists.

• 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
• Prioritise 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

Skills Qualifications

• Relevant 3rd Level Qualification in science or engineering.
• A minimum of 5 years IT validation exp. 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.

If interested please send your CV

Only suitable candidates will be contacted due to the volume of applicants.

Adecco Recruitment Solutions is an Equal Opportunity Employer
Adecco Recruitment Solutions is an Employment Business