Microbiologist & Sterilization Consultant - Cork
A global Medical Device client is seeking an expert in Microbiology & Sterilization to join their team following a restructuring taking place after the new site Quality Head joined.
Contract details:
* 12 month contract
* Full time hours
* Based on site in the west of Cork
* Start dates in February (1 month notice periods acceptable).
It is a contract role, paid on an hourly rate and engaging via a LTD Company set up or Umbrella company.
Key Responsibilities:
* 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, maintenance, 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, interpreting 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)
* Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, bench marking against industry leads and regulatory requirements.
* Coach, mentor, and train other functions in area of sterility and monitoring.
* Support of, ensure compliance of new products to site's sterility standards. Successful integration of products to validated processes.
* Ensures biocompatible of components, materials and consumables used in the manufacture of products.
