Microbiology Manager - County Waterford. At least 5 years' experience in microbiology pharmaceutical laboratory.
Microbiology Manager - County Waterford.
Job Purpose: Manage and co-ordinate all activities in the Microbiology Laboratory including scheduling and people management
1. Site expert on microbiology; providing company-wide guidance and expertise
2. Introduce microbiological testing and provide support to the site including scheduling of all activities within Microbiology laboratory
3. Co-ordinating and managing Microbiology Analysts and supporting them in their role
4. Managing the Microbiology laboratory schedule to support operational activities
5. Perform support equipment URS, equipment implementation and laboratory set up
6. Ensuring that the existing laboratory tools are used to generate and maintain performance related metrics
7. Execution of routine utilities QC-Micro testing and environmental monitoring compliance with cGMP and Standard Operating Procedures
8. Oversee the timely close out of deviations and/or investigations
9. Ensure the timely completion of data reviewing as required
10. To identity training requirements of Microbiology Analysts within laboratory and organize training as required
11. To draft procedures and company documentation as required
12. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
13. Ensure microbiology laboratory personnel adhere to all good housekeeping practices
14. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
15. Representing the Microbiology laboratory at various meetings
16. Ensuring the Microbiology laboratory adheres to highest standards of GLP including right first time
17. Managing all external laboratory testing, ensuring all testing is completed on time in full
18. Recruit, train, manage and develop team
Minimum Qualifications & Experience sought:
Qualified to a minimum of degree level in science discipline with a post-graduate qualification advantageous
At least 5 years’ experience in microbiology pharmaceutical laboratory; start-up project experience an advantage
Previous experience in injection facility/sterile fills desirable
Good working knowledge of Regulatory Guidance for manufacture of sterile fill finish products
Supervisory management experience advantageous
Previous cross-functional project experience
Knowledge of GMP guides
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