Microbiology Lead

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

• 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

• 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