1. TECHNICAL RESPONSIBILITIES To manage and be responsible for all aspects of the day to day delivery of the production service e.....
1. TECHNICAL RESPONSIBILITIES To manage and be responsible for all aspects of the day to day delivery of the production service ensuring that the service complies with all current regulatory requirements within designated rotation. Operating within bounds of COSHH, Health and Safety, GMP, GCP and QA regulations. To develop and maintain personal expertise in all technical aspects of manufacture ensuring his/her own accreditation for all appropriate tasks is maintained at all times. To develop and maintain all controlled documentation such as worksheets and standard operating procedures, in liaison with the Principal Pharmacists, Technical Services and Quality Assurance. To ensure that all relevant documentation is reviewed on a regular basis, updated as necessary and all out of date documentation is taken out of circulation. Ensure stock management of starting materials and final products and be responsive to market changes. To undertake the final product check, for batch products in which he/she has had no production involvement, prior to bonding and transfer to Quality Assurance testing. To ensure that no product is released for use in patients without undergoing the appropriate Quality Assurance process, where relevant. To ensure all quality exceptions and deviations from SOPs are reported to Quality Assurance, are appropriately documented and that resolution of the problem(s) is (are) undertaken in a timely fashion. Investigations are documented, in a timely manner, in accordance with the current practice and error reporting statistics are supplied to the national monitoring scheme. To ensure that all environmental monitoring is carried out, at the required time frequency, by appropriately trained staff. To ensure that regular broth fills, both by individual operators and for particular products are carried out at the required time. To ensure that the clean rooms are operating within specification prior to manufacture. To provide first pass engineering assessments for any facilities and equipment malfunctions. Implement and corrective and remedial actions prior to arranging visits to external contractors. 2. RESPONSIBILITY FOR COMMUNICATION To ensure that communication channels exist within the production unit so that staff at all levels are kept up to date with information that is appropriate with their role. To liaise with the dispensary, procurement and distribution departments and review procedures for requests, preparations and delivery of all products from the production unit to minimise waiting times. To communicate effectively with all users of the service. To chair weekly team meetings. To report all errors using internal reporting systems (EQMS/ Datix) and follow up with QA and relay information to Production staff for CAPA. To attend and contribute to all relevant meetings as required by the department leads e.g production meetings, departmental meetings, education and training. Create and support a culture of collaborative working between all areas of the department. Ensure good customer service culture for external and internal end users. To liaise with other senior staff members, ensuring the most efficient use of staff and facilities on daily and routine operational meetings. 3. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT To support the Principal Pharmacists to determine which Specials medicines can be prepared within the capability of the unit. To be responsible, for the qualification, commissioning and validation of new manufacturing facilities and equipment and subsequent requalification activities. To ensure adequate procedures are written and staff training is carried out, to ensure safe operation. To ensure that the facilities and practices within the Pharmacy Manufacturing Unit meet the standards expected by the Medicines and Healthcare products Regulatory Agency (MHRA). To be present at MHRA inspections of the Trusts facilities and to provide appropriate documentation and answers to questions, as required. Join local and regional networks to support best practice. To undertake other duties as requested by the Principal Pharmacist, Technical Services. The Pharmacy Services of the Royal Free London are constantly evolving to best meet the needs of patients and our healthcare colleagues and partners and this may lead to providing a full and comprehensive pharmaceutical support over 7 days a week. Introduce change control to improve efficiency and quality of the manufacturing processes. 4. RESPONSIBILITY FOR FINANCIAL AND PHYSICAL RESOURCES To ensure accurate stock control is maintained in the Pharmacy Manufacturing Unit and for those items used in both Sterile and Non-sterile Production and that appropriate entries are made on the electronic dispensing system. To run daily stock take activities and rectify and discrepancies in a timely manner. To lead the annual stock-take for relevant area. To obtain quotes and service contracts for outside contractors services repair visits. Raise orders for payments of these services. To ensure timely booking out of materials and products on the electronic pharmacy system ensuring prompt release and inventory management. To ensure all written and computerised records are kept and maintained. Take active role in cost efficiency and waste reduction projects. 5. RESPONSIBILITY FOR LEADING AND MANAGING Complete all general management duties in line with trust policy. For example these will include: o To be involved in the recruitment and selection of full-time production staff and to ensure trust policies on recruitment are followed. o To monitor the performance of staff in their relevant rotations and identify any issues which the appropriate senior member of staff. o Conduct annual appraisal for direct line reports. o To approve annual leave requests for staff working in their relevant rotations, ensuring safe and adequate levels of experience at all times. o To conduct direct line report back to work health interviews for Production staff. To undertake the early stages of Trust personnel procedures such as excessive sickness review and performance and conduct review and maintain suitable records of performance and meetings undertaken within these processes. To liaise with the senior technicians in all areas of Pharmacy Production, together with the other Operations Chief Technician, to provide appropriate management cover, in their absence, to ensure the efficient and safe production of quality products. To oversee the running of the teams and assist/support in the absence of the senior technician. To ensure that communication channels exist within all areas of Pharmacy Production so that staff, at all levels, are kept up to date with information that is appropriate to their role. To ensure that regular staff meetings take place to ensure two way communications between junior staff and management. Ensure section KPIs are monitored and fulfilled on a monthly basis and provide data and support end of month reporting. Responsible for facilities and equipment management in those areas and co-ordinate maintenance and repairs with the trust estates department and external contractors including software systems in the areas. Management of the senior technicians and responsible for co-ordinating the staff within these areas ensuring manufacturing productivity. Organise and co-ordinate Planned Preventative Maintenance (PPM) programs and repair activities to limit downtime in the units. Ensuring there are always sufficient suitably experienced staff available to provide the necessary level of service. To produce the monthly batch production timetable for manufactured products. Distribute staff allocation/ rota according to accreditations and availability daily. Other relevant duties as assigned by the Chief Pharmacist, Principal Pharmacist or Deputy Production Manager. 6. RESPONSIBILITY FOR INFORMATION RESOURCES To work in strict compliance and accordance with MHRA guidance Note 14 The supply of unlicensed medicinal products specials. Ensure compliance with GMP, Good Distribution Practice (GDP), GCP and Falsified Medicines Directive (FMD) regulation and guidance. Operate under the quality management system and attend self-inspections with quality assurance team. To ensure compliance all other relevant legislation, national and local policies and procedures. e.g. The Medicines Act, Health and Safety at Work Act, etc is applied in Pharmacy Manufacturing Unit at all times. To uphold the principles of Clinical Governance within the trust.
