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STERILISATION VALIDATION ENGINEER (GALWA
Company:COLLINS MCNICHOLAS RECRUITMENT |
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Job Reference Number |
14567013 |
Client ID: |
RI/GJ36512CCC |
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Posted On: |
Feb 8 2012 |
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Location: |
GALWAY |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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Our client is one of the leading multinational companies they currently have a requirement for a Sterilisation Validation Engineer based in Galway
Responsibilities:
- Reporting to the Snr QA Engineer, the duties of the position will include but not limited to:
- Working with Engineers to design protocols to ensure that new products/ product packing changes are adequately tested with respect to biological and sterilisation requirements to guarantee compliance to all regulatory standards.
- Attending project meetings.
- Preparing on AGILE (internal document control software system) protocols for validation of new products/ product packaging changes, executing the testing and completing the reports.
- Preparing on AGILE protocols for validation/ revalidation and dose audits of sterilisation processes executing the testing and completing the reports.
- Liaising with manufacturing and R&D engineers to obtain test samples.
- Liaising with test laboratories to issue test details for testing required and to receive test results.
- Ensuring that all required testing is completed in a timely manner and reports approved to meet project timelines.
- Supporting the Regulatory Affairs department in preparing submissions to notified bodies and addressing any questions regarding these submissions.
- Generating AGILE change requests to update sterilisation validation documentation.
- Reviewing all applicable regulatory standards to ensure that requirements are reflected in internal documentation and implementing changes when standards are revised.
- Performing quality audits of external contactors.
- Supporting audits of sterilisation area performed by internal auditors or notified bodies.
- Preparing, in co-operation with IS department, software validations.
- Gathering of information to support problem-solving of sterilisation validation and commercial sterilisation issues.
- Responsible to motivate and develop personnel at lower levels within the department to achieve departmental and organizational goals.
Requirements
- Science qualification to degree level is essential, further post graduate study in a related discipline would be of benefit.
- Minimum of 2-3 years experience in a related area is required. Some training will be given.
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