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VALIDATION MANAGER - LIMERICK
Company:ICDS RECRUITMENT |
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Job Reference Number |
14348026 |
Client ID: |
RI/EM11305 |
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Posted On: |
Jul 29 2010 |
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Location: |
LIMERICK |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Benefits: |
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The successful candidate for this role will:
- 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
- Develop themselves as an expert in their area of responsibility for a long-term support of the operation.
- Prepare monthly reports with emphasis on timing and cost estimation in the area of responsibility.
- 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, J&J 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:
- Bachelors degree from an accredited college or university, preferably in an Engineering discipline
- In-depth knowledge of Validation processes, Medical Product Manufacturing, especially high automated processes or aseptic operations .
- Experience in FDA or IMB regulated manufacturing organisation
- Proven management experience in a Quality organization
- Strong project management skills
- Competent validation knowledge with good organizational/administrative skills
- Effective communication and presentation skills in one-on-one and group situations.
- 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.
- Excellent skills to prepare written policies, procedures and reports.
- Ability to handle various responsibilities simultaneously.
- Able to work rotating shifts and extended hours as required.
- Required to wear clean room gowning and appropriate PPE.
- Self-directed and self-motivated, Customer focus, excellent attention to detail
- Results and performance driven, Adaptable and flexible
