JOB DESCRIPTION Post Details Title of Post: Deputy Microbiology Manager Grade: 6 Department/Directorate: Microbiology Department, Control Laboratory, Technical Department Location: BPL Accountable to: The BPL Microbiologist Main Job Purpose To co-ordinate the activities of the BPL’s Microbiological Quality Plan in terms of investigating adverse microbiological results; assisting the BPL Microbiologist in providing specialist advise to Technical, R&D and Production departments; and to take responsibility for key aspects of the day-to-day operation of the Microbiology Section (as outlined in the duties below), including direct supervision of the Microbiology Technicians / Senior Technicians. To act as a Technical Specialist to review groups, working parties and the section using specific scientific knowledge relating to this discipline. Organisational Structure The BPL Microbiologist Deputy Microbiology Manager Microbiology Technician Key Duties and Responsibilities To perform and maintain a wide range of microbiological tests and procedures according to standard operating procedures. To report results using defined documentation systems. To promptly report any deviations from expected results or documented procedures. To assist in routine data collection and analysis including, for example, statistical process control. To operate a variety of computer software packages for data analysis and related applications. Documentation preparation and review. To clean, calibrate and maintain equipment, and prepare and maintain reagents, standards or control samples. To assist with the training of junior staff in routine procedures. To assist with the introduction and evaluation of novel procedures using defined protocols To participate in the microbiological and physical monitoring programmes in various production areas. To carry out development work on procedures including the design and performance of validation studies and the preparation of validation reports. To take full responsibility for the supervision and training/assessment of junior staff in routine technical procedures and instruction of other staff in novel or developmental procedures. To train staff in other departments such as Engineering and Production in approved techniques that are delegated to those staff on behalf of QC. To assist with the recruitment of Technical staff. To carry out Personal Development Review of allocated Technician staff in accordance with BPL’s PRD scheme. To identify and recommend appropriate staff development activities for allocated Technician staff to ensure that staff achieve the required career progression. To take day to day responsibility for the management of junior staff providing appropriate leadership and direction. To carry out initial counselling on staff performance issues and advise the BPL Microbiologist of difficulties that cannot be readily resolved. To take full responsibility for the co-ordination and planning of a defined area of work and, by appropriate leadership of a team of technicians, to achieve successful completion of routine laboratory objectives on a day to day basis. To take responsibility for ensuring that batch progression targets are met on a day to day basis, and for identifying to the BPL Microbiologist areas of difficulty or potential delays. To monitor and maintain routine test procedures to ensure consistency of results and adherence to compliance requirements at all times. To assist with investigations into abnormal test performance or manufacturing abnormalities, providing input to such working groups as necessary and advising on corrective/preventative actions. To initiate and direct the preparation and revision of SOP’s, report forms and other routine documentation. To help identify the need for new procedures and assist with their development. To generate written project reports. To take responsibility for signing out non-critical or non-batch related test results on behalf of the BPL Microbiologist. Approval and review of results and samples on LIMS. To assist the BPL Microbiologist in preparing monthly reports and review of results and data trends. To attend meetings with senior staff from other departments, such as Production or R&D, to carry out periodic review of operations or process problems. To maintain contact with external suppliers and technical specialists. To work with the BPL Microbiologist and to deputise as required on all matters relating to section administration, staff supervision, compliance and progression of results. To sign out test results as directed by the BPL Microbiologist including inprocess, raw material and final product results where this is considered appropriate. To prepare batch reviews, data analysis and OOS reports at the request of the BPL Microbiologist. To act as technical specialist in defined areas of work and to offer technical knowledge to review groups, working parties, and in completing OOS investigations, and in proposing corrective and preventative actions for Deviation Reports as appropriate. To be responsible for the use of consumables and reagents (including culture media) within the laboratory. To be responsible for stock control across the laboratory. For the ordering of laboratory supplies and consumables. Signing internal stores orders For the careful use, calibration, verification and maintenance of technical equipment instrumentation and computer software packages. To be able to plan out own working day and the work of Microbiology Technician and Senior Technician staff. To prepare work rotas for the section’s activities. To ensure that batch progression targets are met. To ensure that Microbiological Investigations, Deviation Reports and OOS are investigated and progressed against targets. To ensure that document is in date and reviewed appropriately. To ensure that performance reviews for Microbiology Technicians are performed against targets and to assist with staff development and disciplinary issues. To perform performance reviews. To organise the leave and absence records of Microbiology Technicians. To assist the BPL Microbiologist in implementing the microbiological validation programme for BPL. Contact with other technical, supervisory and managerial staff in Technical, Production and R&D departments. Contact with supervisory and managerial staff at appropriate meetings and in the course of investigations. Contact with external suppliers, technical specialists and contract laboratories. To perform a variety of microbiological techniques. To perform microbiological investigations. To remain up to date with current legislation, regulations and specialist knowledge and skills. To plan the work of Microbiology Technicians and Senior Technicians To perform reviews of microbiological data and ensure that the BPL Microbiologist and senior management are aware of microbiological trends. To plan own work on a day to day basis based on the targets of the section. To plan the work of Microbiology Technicians and Senior Technicians To deal with day-to-day issues arising from the laboratory and BPL production To make decisions concerning trends in microbiological data and for data associated with batch reviews. To assist the BPL Microbiologist in determining microbiological policy for BPL To assist with other duties in relation to microbiological quality and laboratory management as appropriate. Acceptance and Review Accepted Manager............................................................. Jobholder........................................................... Reviewed Manager............................................................ Jobholder............................................................ Date Date Date ........................... ........................... Date ........................... ........................... H:\D05\DATA\PERS\Recruitment\Job Descriptions\Technical\Microbiology\Microbiology Deputy Manager JD.doc