Role: - QC Microbiology Assistant Manager- (Pharmaceutical)
Location: Greater London
Russell-Taylor Group has a fantastic opportunity for an experienced Senior Microbiologist/Team Leader/Manager to join our Clients multi sited Pharmaceutical company, who are experiencing growth at this time. The successful candidate will be given the autonomy to grow and manage the Micro and QC Chemistry labs onsite.
The Assistant Microbiology Manager is responsible for the 'day-to-day' management of Microbiology and QC departments, ensuring that all appropriate microbiological standards and regulatory requirements are met, as well as leading and supporting the Microbiology lab to provide a compliant, on time testing service to the site to ensure all required microbiological testing is performed to plan and in accordance with approved procedures and test methods on a permanent basis. You will be responsible for the day-to-day management of the QC Chemistry laboratory, involved in the Raw material analysis. You are responsible for leading QC Raw Material and Microbiology staff.
- Ensuring that microbiological and hygiene aspects of cGMP are understood by all and strictly enforced.
- Implementing, monitoring, and maintaining appropriate standards of control over process, personnel, environment, and utilities to demonstrate compliance with all regulatory and organisational standards.
- Managing the QC Microbiology lab and raw material team to provide a compliant, on time testing service to the site, and develop and maintain quality systems for QC ,including specialized training and microbiological specifications for environmental monitoring, utilities, raw materials, components, in-process and finished product, to ensure that tests meets both organizational and Regulatory agency policies, guidelines and the registered Marketing Authorizations.
- Maintaining expertise in current pharmaceutical microbiology topics and regulations to provide accurate -technical input on QC Microbiology and Operations inspection readiness as well as the most efficient and comprehensive methods for preventing microbial contamination of the organization's products.
- Responsibility for QC compliance in accordance with GMP.
- Providing leadership and management within the laboratories through a structural process of objective setting, performance appraisals and individual development.
- Improving the overall department productivity and efficiency in order to meet KPI's.
- Ensuring robust training and self-inspection programmes within the laboratory, as well as the review of SOPs, investigations, specifications, methods and validation reports.
- Implementing new processes and procedures.
- Maintaining the risk-based and scientific-based quality system as part of the Quality unit.
- Establishing and maintaining efficient workflows to ensure operational excellence.
- Leading internal and external QC audits.
- Leading OOS/OOT investigations.
- The Person:
- 4 years' experience of working in a sterile/non-sterile pharmaceutical environment.
- Experience with the MHRA or USFDA regulated industry
- Team Management experience is a must
- Will hold a Microbiology qualification or Science Degree with the above experience in a Micro setting.