Collins McNicholas

Role Responsibilities:

  • Generating site trends (utilities) whilst supporting the identification of appropriate corrective and preventative actions. 
  • Provide QC representation on the Critical Utilities Team. 
  • Provide technical troubleshooting support during site failure investigations. 
  • Support the deployment of rapid micro techniques & new emerging technologies that may be applied in QC. 
  • 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. 
  • 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. 

Role Requirements: 

  • 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.

 

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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