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Location: |
Connacht
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Qualifications: |
Degree |
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Experience: |
4-5 Years |
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Job Type: |
Permanent
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Salary: |
Negotiable |
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Consultant: |
Brian Christensen |
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Microbiology Supervisor
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Microbiology Supervisor
Summary
Reporting to the Quality Manager, the role of the Microbiology supervisor is to manage all aspects of a busy micro lab in compliance with GMP.
Responsibilities:
1. Manage Microbiology Department; budget, personnel, and ensure that objectives are set, monitored, and completed in proper priority.
2. Provide sterility assurance expertise to both plants
3. Oversee sterilization testing, and testing to support manufacturing and new product development.
4. Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
5. Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
6. Coordinate daily operations for a team of microbiologists and laboratory assistants
7. Establish a career development program to recruit and retain laboratory staff.
8. Review and approve laboratory testing documentation.
9. Facilitate laboratory investigations.
10. Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
11. Assist in the writing of functional area status reports, regulatory documents, and process descriptions.
12. Maintain environmental monitoring program.
13. Maintain risk assessments required for parametric release
14. Management of lab equipment including, Qualifications, e.g. IQ/OQ, calibration and maintenance.
15. Participate in all GMP and operational training programs & complete all Training Records.
Education/Experience Requirements:
• Degree in Microbiology
• A number of years experience in a regulated pharmaceutical environment including some people management experience.
• Experience of environmental monitoring and bacterial endotoxin testing.
• Familiarity and understanding of FDA and EU requirements.
• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
• Experience in supervising and motivating a team, project management experience and meeting deadlines.
• Excellent communication and interpersonal skills essential, proactive approach to work essential.
• An ability to work independently as well as a member of a team in a dynamic, fast-paced environment essential
For further information please contact Brian Christensen on +353 1 685 47 47 or email brian.c@lifescience.ie
For immediate consideration please apply online now.
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