Telephone: 086 8395533
Our client, a Medical Device company in Galway is currently looking to recruit an Plant Microbiologist or their site.
Education & Experience:
- A degree in Microbiology or a related discipline
- Minimum 3 years of experience in microbiology experience in a regulated environment
- Experience in an FDA-regulated environment preferred
- Knowledge of Quality Systems Regulations, ISO guidelines and good laboratory practices
- Good communication and organisational skills.
- Ability to work as part of a team and on own initiative.
- Thorough knowledge in the external regulatory requirements (QSR, ISO, EN) in the following subjects: microbial environmental monitoring, contamination control, and quality assurance.
- Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
- Owns and maintains the microbiology environmental monitoring program
- Review and trending of Environmental Control testing (water/air/surface microbial) of controlled areas within the plant according to documented procedures.
- Oversees the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Provide technical guidance/ trouble shooting in the event of equipment failure, NCEs or out of specification results.
- Participate in the investigation of laboratory investigations as needed and implements corrective action as appropriate
- Support new product introductions by participating as the microbiology functional team member.
- Participate in cleaning and process validation activities involving microbiology as needed.
- Final review and approval of protocols, reports, SOP’s etc.
- Microbiology representation and participation in cross functional site meetings.
- Participate in regulatory Inspections
- Proactively identifies and implements improvements and lean initiatives.
For further information on this Plant Microbiologist role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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