Our client is a vaccine manufacturing facility based in Ballina in Mayo, currently recruiting a Microbiology Team Lead. This role reports directly to the Operations Manager and presents an opportunity to join a positive and dynamic team at an exciting time when the company is poised for growth.
Role
1. Support the scale-up of production operations on-site in Ballina, delivering on ambitious plans to service the global vaccine, oncology & therapeutic industries by the efficient processing and accurate reading/reporting of microbiological samples.
2. Ensure regulatory & quality compliance is applied to SOP writing/updating and the periodic reviews of the same.
3. Be familiar with relevant regulations provided by the European (EP) & American (USP) Pharmacopeia.
4. Ensure all documented procedures are being followed & all logbooks/documentation is completed in real-time and is right first time (RFT).
5. Build, lead & develop a strong Microbiology Lab team with assistance/mentoring from the management team.
6. Manage and coordinate laboratory team members' daily/weekly tasks while evaluating individuals' strengths & weaknesses to mitigate these.
7. Perform EM, water, microbial limit testing, bioburden testing, and sterility testing using laboratory techniques/cGLP, quality control, and utilizing laboratory skills.
8. Be involved in any/all investigations arising from positive results, non-conformances, and/or human error deviations.
9. Review & interpret all routine & requested microbiology results.
10. Record/tabulate laboratory results and present at management meetings.
11. Conduct quality control (QC) checks, preparation & revision of SOPs, qualification/validation of test methods.
12. Lead continuous improvement projects for current laboratory processes.
13. Conduct routine preventative maintenance on all laboratory equipment and schedule routine servicing to ensure that the laboratory is stocked with all necessary materials & consumables.
14. Supervise/maintain the flock sampling schedule and compile/review results.
15. Ensure all gowning & PPE is being worn correctly in relevant areas.
Requirements
1. Education: Level 8 Degree in relevant microbiology discipline; a Masters/PhD in a microbiology discipline would be a distinct advantage.
2. Minimum 3 to 5 years in a regulated GLP environment.
3. Previous experience in the vaccine manufacturing industry would be beneficial.
4. Exposure to dealing directly with suppliers & customers would also be an advantage.
5. Exposure to people management is beneficial but not essential.
6. Strong leadership skills, including team building, relationship building, and effective stakeholder management.
7. Excellent communication, presentation, and interpersonal skills.
8. Background/exposure to aseptic techniques & isolators is beneficial.
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