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QUALITY ENGINEER
Company:PHARM ENG LTD |
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Job Reference Number |
14291290 |
Client ID: |
RI/PEK777KGK |
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Posted On: |
Mar 8 2010 |
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Location: |
TIPPERARY, MUNSTER |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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Role:
- Resolve and assist in the closure of deviations initiated during production and follow up in the on-site Quality System as required
- Participate in the development and implementation of the manufacturing processes for existing and new products.
- Review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ) including the inspection and sampling plans.
- Responsible for the Development and implementation of process sampling plans, procedures and statistical techniques; and specification of inspection and testing procedures to support startup of facility.
- May conduct training on quality assurance concepts and tool.
- Interfaces with the project teams on quality system related issues.
- Several years experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Experience in Process Validations, Risk Assessments, Documentation or Operations.
- Familiarity with relevant business processes, systems and medical device products
- Ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
