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QC Analyst – NPI

Job Title: QC Analyst – NPI
Contract Type: Contract
Location: Cork
Industry:
REF: 98179
Job Published: about 1 month ago

Job Description

Contact: Niamh Hlubek
Email: recruit@hero.ie
Telephone: 086 8168298

QC Analyst – NPI

Our client, a medical device company in Cork is currently looking to recruit a QC Analyst - NPI for their site.

Roles and responsibilities for this position include:
  • DPFD (Design process flow diagrams) review/approval.
  • Bill of Testing creation (this includes both product BOT, Media BOT and column packing BOT).
  • Support Transfer of new assays to QC.
  • Introduction of new raw materials.
  • Creation of documentation for new products e.g. gap analysis, validation/verification protocols, validation/verification reports, GMP memo, test method updates.
  • Organize non-routine samples for microbiology method verification.
  • Monitoring method validations/method verification execution.
  • Monitoring the first batch execution-review campaign technical reports.
  • Attending weekly product related meetings with sister sites and other Cork site departments.
  • Updating quality agreements and manufacturing licenses.
  • Change control creation, review & approval and Investigation authoring.

For further information on this QC Analyst - NPI role in Cork please contact Niamh Hlubek 086 8168298 / recruit@hero.ie

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