job description

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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
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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.
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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
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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
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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.
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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
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Date ...........................
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