Mundipharma Research Ltd Job Description JOB TITLE: Scientist Grade 3 and Grade 4 SECTION: DEPARTMENT: Technical Support COMPANY: Mundipharma Research Ltd RESPONSIBLE TO: Section Manager Technical Support DATE: A. Technical Support August 2013 BROAD PURPOSE OF JOB To provide scientific input and practical analytical support for the Technical Support Department and Analytical & Pharmaceutical Sciences Department by cleaning and maintaining the designated areas and equipment used for manufacturing and testing of products. Take a proactive approach in undertaking general routine maintenance and calibration of equipment within the laboratory areas. B. SPECIFIC DUTIES & RESPONSIBILITIES 1. Undertake glassware cleaning, routine maintenance, verification and calibration of equipment and services, to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Standard Operating Procedures (SOPs). Ensure tasks, as assigned by the Section Manager or Supervisor are completed and progress of work is reported, as and when required. 2. Record actions, data and results for equipment and services calibrations, verifications and maintenance in accordance with the relevant SOP. Give guidance and advice to other team members. 3. Prepare reports and presentations for the supervisor or manager. Review new or revised documentation and prepare and write documents where applicable to the work of European Technical Development. 4. In accordance with security guidelines, carry out the induction and supervision of service engineers working in the European Technical Development areas. 5. Maintain stocks of chemicals, solvents, gases and consumables and advise when replacement stocks are required. Receive deliveries and store in the appropriate locations. Connect gas cylinders to relevant laboratory gas lines as required. Ensure and supervise appropriate and timely disposal of solvent and pharmaceutical waste. 6. Ensure inventory control and stock movements between the relevant departments are carried out in line with the current legislation. Conduct regular housekeeping audits to ensure completed studies are removed from storage. 7. Provide assistance in the planning and co-ordination of supporting services, equipment calibration, validation and maintenance schedules. As appropriate, work with other groups and departments to ensure best use is made with the time available and that the resources are utilised efficiently and agreed target deadlines can be met. 8. Recommend the purchase of and evaluate new equipment as required. 9. Use computer software packages such as LIMS, Empower, SmartLab, Chromatography Data Systems, electronic notebooks, MS Office (Outlook, Word, Excel and PowerPoint), document management systems, collaborative tools and the Internet. 10. Review relevant literature in order to obtain background information in relation to projects being undertaken and maintain a current awareness of trends in the pharmaceutical industry and recommend appropriate action where necessary. Suggest innovative methods of work and improvements to processes to improve working efficiencies and make use of new technologies. 11. Carry out specific training for other team members, in order to maintain and develop the effectiveness of the Department, ensuring individual training records are completed and kept up to date. 12. Take responsibility for personal training and development in order to reach and maintain the required level of skills, knowledge and experience to perform the role. Maintain accurate training records. Proactively participate in the company Performance Assessment System, including the agreement of objectives which meet the business requirements and enable personal development and progression. 13. Ensure the maintenance, cleanliness and validation status of laboratory equipment and facilities are appropriate for the work to be undertaken and in accordance with the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Standard Operating Procedures (SOPs). Maintain the provision of controlled environment storage within European Technical Development. 14. Ensure all work is undertaken in compliance with the requirements of cGxP (Current Good ‘Clinical, Laboratory, Manufacturing, Pharmaceutical’ Practice), relevant codes of practice (e.g. Medicines Act 1968, EU Directives) and company/departmental SOPs. Ensure compliance with the requirements of Control of Substances Hazardous to Health (COSHH) and Health and Safety at Work Act 1974 (HASAWA). 15. Undertake any other reasonable tasks to help fulfil the objectives of the Department.