Microbiology Lead
| Job Type | Fixed Term |
| Area | Mayo, Ireland |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1003284 |
| Job Views | 309 |
- Description
Team Horizon is seeking a Microbiology Lead for our client based in Mayo.
Why you should apply:
- This is a challenging opportunity and a chance to work in a diverse team with a great mix of people. Joining our client means joining a team that you can truly learn from.
- Employees are encouraged to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers.
- You are ambitious and desire a career with an innovative forward-thinking company.
What you will be doing:
- Responsible for the supervision of the Microbiology Department and a team of microbiologists.
- Coordinate daily operations for a team of microbiologists and laboratory assistants; ensure that objectives are set, monitored, and completed in proper priority.
- Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required.
- Responsible for the generation of documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.
- Responsible for the identification and communication of adverse trends in routine microbiological monitoring
- Oversee sterilization testing and testing to support manufacturing and new product development.
- 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.
- Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
- Review and approve laboratory testing documentation.
- Facilitate, perform and review laboratory investigations.
- Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
- Assist in the writing of functional area status reports, regulatory documents, and process descriptions.
- Maintain environmental monitoring program.
- Maintain risk assessments required for parametric release.
- Management of lab equipment including, Qualifications, e.g. IQ/OQ, calibration and maintenance
- Participate in all GMP and operational training programs & complete associated Training Records
- Participate in internal and external audits (including regulatory)
What you need to apply:
- 3rd level Degree in Microbiology or relevant experience in a similar field 5 years or more experience in a regulated pharmaceutical environment including people management experience.
- Experience of environmental monitoring and bacterial endotoxin testing Familiarity and understanding of FDA and EU pharmacopoeial 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
