QC Process Microbiologist

  • Cork
  • Temporary 12 months
  • JO-1908-64689_1565189514

Summary

RESPONSIBILITIES:

* Generating site trends (utilities) and annual reports whilst supporting the identification of appropriate corrective and preventative actions.
* Supporting the delivery of aseptic technique training to site.
* Act a QC micro liaison with Operations, supporting Plant Microbiologist with process related investigations.
* Provide technical troubleshooting support during site failure and lab investigations.
* Provide QC representation on the Critical Utilities Team.
* Provide internal & external technical troubleshooting of QC Microbiology testing methodologies and techniques.
* Collating and reviewing of QC related data used to support regulatory filings in addition to addressing any requests for information from health authorities.
* Ensuring that our microbiological testing strategy is consistent with GMP requirements (Annex 1 & Annex 2 EU GMP) and company requirements as per Platform.
* Support the deployment of rapid micro techniques & new emerging technologies that may be applied in QC.
* Provide internal & external support during audits to QC and OPS.
* Ensuring that the design and qualification of QC testing is performed according to GMP requirements.
* Ensuring that activities are carried out in compliance with cGMP and company quality standards. Understanding and supporting current regulatory trends and future testing requirements and participating in relevant internal and external QC related audits.

RESPONSIBILITIES:

* An MSc or BSc in Microbiology or related Scientific discipline.
* 5+ years' experience within a regulated biologics or pharma industry with a preference for candidates with prior Process &/or QC Microbiology experience.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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