- 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.
- 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 firstname.lastname@example.org