To Take Responsibility for Key Aspects of the Day to Day Operation of the Chemistry Section

1

1. To take responsibility for key aspects of the day to day operation of the Chemistry Section and deputise for the Section Manager as required. Deliver and support on the job training, perform supervisory, developmental, investigative and validation work as approved by the Manager.

1. To contribute to the analytical service provided by the section, through competently testing samples in accordance with the laboratory's Standard Operating Procedures, Policies and the principles of GMP.

1. Where applicable, to perform testing in accordance with the principles of GLP, in support of and where required by, GLP studies.

1. To ensure the range and quality of routine analysis is maintained, in order to provide a professional service to the organisation.

1. To act as a Technical Specialist to review groups, working parties and the Section using specific scientific knowledge relating to this discipline.

1. To perform and maintain in satisfactory operation a wide variety of chemical / biochemical tests and procedures in accordance with SOP’s, GMP and health and safety.

1. To assist in routine data collection and analysis including, for example, Internal Control Samples (IQC).To report results using defined documentation systems.

1. To promptly report and ensure investigation of any deviations from expected results or documented procedures. To assist with investigations into abnormal test performance or manufacturing abnormalities, providing input as requested.

1. To take responsibility for and deliver training and assessment in support of both junior and established staff development.

1. To clean, calibrate and maintain equipment and prepare and maintain reagents, standards or control samples and contribute to general laboratory housekeeping duties.

1. To operate a variety of analytical instrumentation and sophisticated computer software packages intended for data analysis and collation and other related applications (e.g. LIMS).

1. To initiate and direct documentation preparation, revision, review and administration activities. To also help identify the need for new procedures and ensure their appropriate and timely introduction.

1. To assist in the compilation, checking and archiving of laboratory records.

1. To assist with the introduction and evaluation of novel techniques, using defined protocols.

1. To perform development work on procedures including the design and execution of validation studies and the preparation of validation reports.

1. To assist the Method Development Specialist with validation of laboratory equipment and automated systems.

1. To assist with the recruitment of staff at Technician level.

1. To mentor and carry out Performance Appraisal for allocated staff in accordance with company systems.

1. To take day to day responsibility for the management of allocated staff, providing appropriate team leadership and direction. To carry out initial counselling on staff performance issues and advise the Chemistry Manager of difficulties that cannot be readily resolved.

1. To take full responsibility for the co-ordination and planning of a defined area of work, to achieve successful completion of routine laboratory objectives. Ensuring that batch progression targets are met on a day to day basis, and for identifying to the Chemistry Manager, areas of difficulty or potential delays.

1. To generate written project reports as required.

1. To assist the Chemistry Manager in preparing monthly reports and data trend reports.

1. 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.

1. To maintain contact with external suppliers and technical specialists.

1. To perform a leading role in the receipt of section audits from internal (BPL) and external sources.

1. To observe laboratory health and safety instructions regarding the use of personal protective clothing and equipment, and contribute to the development and improvement of safer working practices. To perform and review general risk assessments.

1. To work with the Chemistry Manager and deputise as required on all matters relating to section administration, staff supervision, compliance and progression of results.

1. To review and release (approve/sign-out) test results as directed by the Chemistry Manager, including non-critical, non-batch related, in-process, final product, raw materials and utilities results as appropriate.

Accepted

H:\D05\DATA\PERS\Recruitment\Job Descriptions (JD)\Quality Group\Chemistry\2015\Deputy Chemistry Manager JD Revised Oct 2015.docx1