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Sr Staff Microbiologist Role, Macroom, Cork
Hybrid - 3-4 days onsite
Your key responsibilities:
* Define local quality strategy to deliver safe, high-quality clean and sterile products while maintaining regulatory compliance
* Oversight of Micro & Sterility key processes cleaning, cleanroom, sterilization and product testing
* Coach, mentor, and drive awareness to other functions in area of Micro & Sterility
* Subject matter expert to internal & external regulatory requirements (Corporate, FDA, ISO) and local procedure owner
* Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
* Review and approval Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reports
* Timely communication, escalation, resolution of product issues causing supply chain disruptions
* collaboration for cleaning/ sterilization/ environmental across sites in a global team across T&E Franchise
* Continually identifies opportunity to drive efficiencies and margin improvements
* Support compliance to Micro & Sterility standards in product transfers and new product introductions
What are we looking for:
* Bachelor’s degree/ Master of Microbiology or equivalent
and
* Minimum of 6 years relevant experience
* 2 years Microbiology related experience.
* Experience in interacting with regulatory agencies (MDSAP, FDA, MoH, TUV, etc.) required.
* Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
* Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
* Strong interpersonal skills.
* Strong written and oral communication and negotiations skills.
* Strong in critical thinking and "outside the box" thinking.
* Highly developed problem-solving skills.
* Strong analytical skills.
* Demonstrated ability to successfully manage and complete projects in a matrix organization.
* Demonstrated ability to work independently.
* Experience in working in a compliance risk situation.
* High proficiency in statistical techniques, data review and analysis.
* High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
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