Microbiology and Sterility Assurance Lead
On-siteDublin, Leinster, Ireland
Job Summary
Ensure effective sterility assurance and environmental monitoring programmes are deployed in Dublin Compounding facilities in compliance with current GMP and global strategy. Support the Global compounding organization on standardization of sterility assurance practices, identification/implementation of new technology for microbiological testing, and environmental control. Participate in continuous improvement projects, provide expert guidance for risk reduction initiatives, and lead problem-solving investigations for product deviations, customer complaints, and quality incidents. Provide technical support in interpreting microbial identification and environmental monitoring data, including setting appropriate alert limits, and track/report quality metrics for internal and external use. Carry out validation and experimental design in association with the EMEA Sterility Assurance Manager, audit external lab service levels, and develop quality documentation including local SOPs. Deliver microbiological and aseptic operator training to operational and quality staff, including periodic reassessment.
Required Qualifications
- Degree in Microbiology
- 3 years experience in implementing environmental control programs and OOL investigation and correction
- Must have strong operational experience preferably in an aseptic manufacturing background
- Experience of aseptic technique
- Excellent interpersonal skills
- Passionate advocate of quality as a discipline and continuous improvement
- Experience in the use of quality improvement and problem solving skills (ie FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean manufacturing
- Experience of critical equipment and process Change Control
- Experience of validation of microbiological methods or sanitization processes
- Able to work autonomously and take the initiative
- Demonstrate Critical thinking and decision making
- Collaboration and teamwork
- Dealing with ambiguity
- Good management and communication skills
- Customer and patient focus
Desired Qualifications
- 5 years experience of microbiology experience in an aseptic facility
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