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QA VALIDATION ENGINEER
Company:CPL |
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Job Reference Number |
14563754 |
Client ID: |
RI/JO-1110-237441 |
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Posted On: |
Jan 31 2012 |
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Location: |
MUNSTER COUNTIES, LIMERICK |
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Job Type: |
Permanent |
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Salary: |
NEG |
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A leading multinational based in Limerick is currently looking to recruit a QA Validation engineer
Responsibility
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
• 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
Skills & Qualifications
• 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.
For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.
QA, Quality Assurance, QA Validation Engineer, Senior QA Validation Engineer, Validation Engineer, Engineer, software engineer
