Assistant Manager, QC Microbiology, Pharmaceutical
Salary: Competitive, plus additional benefits
Our Client, a multi sited Pharmaceutical company, who are experiencing growth at this time - is looking to recruit for an experienced Senior Microbiologist/ Manager who 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 in order 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.
- Strong Microbiology Management or Leadership experience within a Pharmaceutical - MHRA regulated industry
- Will hold a Microbiology qualification or Science Degree with the above experience in a Micro setting.