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SENIOR MICROBIOLOGIST - SLIGO - CONTRACT

 

Company:

COLLINS MCNICHOLAS RECRUITMENT
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Job Reference Number

14566531

Client ID:

RI/SJ36607
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Posted On:

Feb 7 2012

Location:

SLIGO
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Job Type:

Contract

Salary:

NEGOTIABLE
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Our client based in Sligo is looking for a Senior Microbiologist to cover a maternity leave for a 6 -9 month contract.

Primary responsibilities:

  • 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:

  • Experience in medical device or related industry.
  • Has worked in microbiology role for at least 2 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
  • Educated to Degree level in Science / Microbiology
For further details, please contact Aideen Cummins on 071-9142411 or email aideen.cummins@collinsmcnicholas.ie