Microbiology Lead

  • Mayo
  • Team Horizon
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