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VALIDATION MANAGER
Company:NOEL RECRUITMENT |
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Job Reference Number |
14276282 |
Client ID: |
RI/EMVALMGR0005 |
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Posted On: |
Feb 8 2010 |
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Location: |
LIMERICK |
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Job Type: |
Permanent |
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Salary: |
COMPETITIVE |
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Benefits: |
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Manage all of the validation engineering functions at the site. Lead, integrate & project manage validation tasks from initial concept through to successful completion and delivery. Continue to seek, support & drive cost saving initiatives where validation is involved or accountable for the functions.
Develop the plans and resource requirements including skill mix to deliver the validation objectives whilst supporting development needs and operational efficiency. Co-ordinate validation activities with all stakeholders through commercialization.
Implement validation processes and site master validation planning. Close co-ordinations with other functions such as engineering, quality assurance, safety, operations and production. Prepare monthly reports with emphasis on timing and cost estimation in the area of responsibility. Follow cGMP guidelines, safety procedures, and SOPs at all times.
Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities. Be accountable that validation activity is conducted in compliance with US and EU legislation; as well as, Company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
Provide processes for validation activities in compliance with global regulations, GBSC procedures and EHS requirements. Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls). Execute qualification protocols as required. Prioritize qualification activities in line with the project schedules and plant priorities.
Participate in cross-functional teams as required and Work in other areas as needed.
Qualifications and Experience
Engineering graduate with 8 years plus in-depth knowledge of Validation processes, Medical Product Manufacturing, especially high automated processes or aseptic operations. Experience in FDA or IMB regulated manufacturing and proven management experience in a Quality organization. Strong project management skills and Competent validation knowledge with good organizational/administrative skills.
High proficiency in using Microsoft Word, Excel, PowerPoint and MS Project. Manufacturing Execution System design and implementation. Ability to understand manufacturing processes, and to identify improvements. Able to work rotating shifts and extended hours as required.
FOR A CONFIDENTIAL DISCUSSION CONTACT EUGENE MURPHY 061 464944
