* 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.
* Focus on patients and customers at all times.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists