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QC Process Microbiologist

  • Job reference: 926953
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 07/08/2019

Orion Group are looking for a QC Process Microbiologist for our multinational pharmaceutical client based in the Cork area on an initial 6-month contract with the potential to extend.

Main Responsibilities of the role

  • 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

Desired Experience and Background of the successful candidate

  • 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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