Telephone: 086 0449476
Our client a medical device company in Cork. Due to continued expansion of our Clients operations, we are seeking applications from a suitably qualified and experienced Microbiologist I
The purpose of the Site Microbiologist I role is to work as a team with the Site Microbiologist to provide technical support on a range of microbiology issues impacting various operational departments and cross functional project teams as required. Review and assess from a microbiology context all changes that impact product or the cleanroom environment including the introduction of new products.
- Primary Commitment to patient safety and product Quality and the delivery of key Quality and Performance Objectives.
- Ensure Regulatory compliance in Microbiology to cGMP’s of all medical device regulatory agencies (e.g. FDA, TUV & DEKRA).
- Provide expertise to support functions on Microbiology related issues (e.g. regulatory requirements, microbiological impact of product/process changes, product endotoxin, product Bioburden)
- Co-ordinate and train to ensure a high Quality and Compliance awareness in the Laboratory
- Perform Environmental Monitoring at the plant (Microbial, Particulate, Water).
- Perform product testing (Bioburden and Endotoxin).
- Ensure compliance to all Laboratory and relevant plant wide procedures and practises.
- Involvement in ordering materials for laboratory.
- Prepare for and participate in audits.
- Daily review and approval of Laboratory data and documentation
- Co-ordinate and or perform validations of new products
- Provide leadership to Technician I & II roles and maintain safety awareness in the Laboratory.
- Attend and represent Microbiology at meetings and project teams.
- In conjunction with the Laboratory Supervisor ensure a cost effective and efficient service is provided.
- Schedule testing as required and in the absence of the Supervisor oversee the day to day operation of the lab.
The Ideal Candidate
- Level 8 qualification in Science, Microbiology or related discipline.
- Ideally 2 years work experience within a regulated environment.
- Ability to work on own initiative.
- Strong Team Player and excellent collaborator.
- Experience in investigation and problem solving.
For further information on this Microbiologist I role in Cork please contact Orla Crowley Healy 0860449473 / email@example.com
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