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SENIOR MICROBIOLOGIST - PERM
Company:HUDSON GLOBAL RESOURCES LIMITED |
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Job Reference Number |
14565165 |
Client ID: |
RI/IE656609 |
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Posted On: |
Feb 3 2012 |
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Location: |
SLIGO, SLIGO |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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*Approval of all sterilisation /microbiological exception documents, quality system procedures and specification documents.
*Establishment of procedures and plans that define those elements necessary to meet regulatory business and customer requirements.
*Ensuring that Quality procedures and instructions are understood, implemented, maintained and accessible to the appropriate personnel.
*Approval of Plant Environmental Monitoring Programme, Monitoring performance and advising management personnel on quality issues.
*Approval of Plant Housekeeping Procedures.
*Internal Auditing of the Quality System with other team members.
*GMP Training Programme - presented Plant wide.
*Training Lab personnel in relevant micro procedures.
*Sterilisation Validation - development of validation protocols and completion of relevant documentation.
*HVAC Validation - Development of validation protocols, testing and completion of relevant documentation.
*Participation on plant projects and contributing to EHS, manufacturing and engineering related initiatives.
Requirements:
Degree in Microbiology.
*Experience in medical device or related industry.
*Has worked in microbiology role for at least 4 years
*Has proven knowledge of ISO / EN / FDA validation and change control regulations as they relate to medical devices.
*Appreciation/knowledge of current medical device regulatory environment or other aspect would be desirable.
*Experience with Ethylene Oxide product sterilization would be advantageous.
*Has CAPA and audit experience
*Enthusiastic and energetic with the ability to integrate quickly into a team environment
*Demonstrated flexible and innovative approach to work.
For further information on this and other similar jobs please contact Áine O' Donoghue on 01- 256 8716 or email her at aine.odonoghue@jobs.hudson.com
Hudson is a leading provider of permanent recruitment, contract professionals and talent management solutions worldwide. Please note you will receive an automated response advising you that we have received your CV.
