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Microbiologist - Sterilization - Contractor in Germany

Job Title: Microbiologist - Sterilization - Contractor in Germany
Contract Type: Permanent
Location: International
Industry:
REF: 89166
Job Published: about 1 month ago

Job Description

Contact: Jenny Dore
Email: jenny@hero.ie
Telephone: 0860449371

Microbiologist - Sterilization - Contractor
Our client, a leading Medical Device organisation in Stuttgart Germany are looking to recruit a Microbiologist - Sterilization Contractor on an hourly rate basis.


What will I be doing?
  • Working with Engineers to design protocols to ensure that new products/ product packing changes are adequately tested with respect to biological and sterilization requirements to guarantee compliance to all regulatory standards.
  • Attending project meetings.
  • Preparing on AGILE 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 sterilization 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 sterilization 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 sterilization area performed by internal auditors or notified bodies.
  • Gathering of information for support problem-solving of sterilization validation related issues.
What do I need?
  • A Science qualification to degree level is essential, further post graduate study in a related discipline would be of benefit.
  • Excellent verbal and written communication skills are essential for this role; a good working knowledge of process validation requirements would be beneficial.
  • A minimum of 2 years' experience in a related area is required. Some training will be given.
For further information on this Microbiologist - Sterilization - Contractor role in Galway please contact Jenny Dore on 0860449371 / jenny@hero.ie
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