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Carrigtwohill, CO, T45 RP21, IE
Job details
Work flexibility: Onsite
Req ID: R537686
Employee type:
- Temporary
- Full Time
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Job description
12 month contract with full Stryker benefits
What you will do:
Will work within the microbiology team, under general supervision, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following:
- Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards.
- Monitoring of utilities including all grades of water, and where necessary, compressed air.
- Co-ordination of samples for bioburden and endotoxin testing.
- Ordering consumables (media etc) and general stock for day-to-day running of laboratory.
- Applying cGLP to all laboratory activities including stock control.
- Performing sampling for validations and re-qualifications as required.Review of validation files for compliance.
- Strong interactions, maintainance and support of sterility suppliers.
- Interact with Supplier quality team with respect to vendor sterility topics.
- Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
- Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
- Performs sterility release review, intepretaing data and trends.
- Performs sterilisation validations and re-qualifications in line with relevant BS EN ISO standards.
- Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
- Mentors and trains team and cross functional groups as required (induction, GMP etc)
- Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
What you will need:
- Bachelor degree/ Masters of Microbiology or equivalent (Level 8)
- Minimum of 2 years in Microbiology/Quality/Regulatory Affairs environment
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