Are you an experienced Microbiology Manager? Have you previously worked with Sterile products? I am recruiting on behalf of an expanding pharmaceutical client, who are excited to hear from experienced Microbiology Managers.
£40,000 - £45,000 per annum + extensive benefits package
As a Microbiology Manager, you will be planning the workload for a small Microbiology team dependent on the manufacturing schedule of sterile and non-sterile products.
The responsibilities of the Microbiology Manager include:
• Responsibility for Microbiology compliance in accordance with GMP.
• Providing leadership and management within the laboratories through a structural process of objective setting, performance appraisals and individual development.
• Leading internal and external QC audits and leading OOS investigations.
• Managing and completing QMS actions in a timely manner.
• Interpret data and review and approve method suitability, Data checking and approval in Microbiology department.
• Managing the testing of raw materials, finished Products, Stability Samples and Investigational Samples using microbiological techniques (PET, TAMC/TYMC).
• Managing the environmental monitoring for clean room, Bacterial Endotoxins and sterility testing.
• Performing Gowning qualification, autoclave operation and Bio indicators enumeration and disinfectant study for sterile facility.
• Responsible for microbiological test implementation of new compounds: method development, validation and documentation.
• Managing the cleaning validation by using swab/contact technique.
• To write reports, SOPs and other documentation when required including Monitoring and trending of microbiological data
The ideal candidate for the Microbiology Manager post will have:
• A BSc or equivalent in Microbiology or biological science
• 5 years of experience working in a pharmaceutical Quality department in clean room/sterile and non-sterile environment. Plus 2 years experience in a leadership function.
• Deep understanding and proven application of cGMP regulations and international guidelines in a sterile/clean room and non-sterile area.
• Capable of working to deadlines and prioritize multiple tasks with flexibility to change based on priority
If you are an experienced Microbiology Manager with sterile product experience then please apply now!