Band 8b Quality Assurance Specialist
2 weeks ago
Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This larger scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients.
Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research and we will continue to measure our progress against our five governing objectives: excellent outcomes, excellent patient and staff experience, excellent value for taxpayers’ money, being safe and meeting our external duties, and building a strong organisation.
Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.
**Detailed job description and main responsibilities**:
**1.** **RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT**:
- To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality
- To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.
- To ensure Trust GMP Internal Audit Programme and audits are reported and actioned in a timely manner.
- To ensure QA requirement for validation master plan are fully completed and documented
- To assist in the review of service contracts and technical agreements with suppliers.
- To assist in the review and update of QA/QC procedures.
- To assist in the review and update of specifications for raw materials, finished products, packaging materials and labels.
- To assist in the review, update and approval of manufacturing documents and procedures.
- To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.
- To act as a Quality Controller for piped medical gases adhering to the requirements of HTM02 and assist in providing medical Gas Testing service across the sites
- To assist in the qualification, commissioning and validation of new facilities and equipment.
- To assist in the approval of standard operation procedures within the Pharmacy Production and QA/QC units.
- To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.
- To undertake GMP audits of external suppliers as required.
- To assist in maintaining the Quality Management System used by all Trust licenced facilities. This involves effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.
- To assist in the effective management of the Change Control and Unusual Events programme ensuring improvements and any regulatory changes are assessed and implemented.
- To assist in the development and management of a robust document control system as an integrated part of the Quality system according to GCP and MHRA requirements.
- To establish and implement procedures for the department wide temperature monitoring system in the medicine storage areas which includes but not limited to pharmacy production and preparation areas, dispensary areas, stores and clinical trial areas and review record of alarms generated.
- To respond to customer complaint and investigate and report on defective medicines for Trust manufactured products.
- To coordinate the trust response to Drug Alerts issued by the MHRA.
2. STAFF SUPERVISION AND TRAINING
- To train and supervise the work of the laboratory technical staff to undertake method development and ensure that activities undertaken meet current legislative guidelines such as GMP/GDP. GCP, Health and safety, COSSH.
- To assist in managing staff assigned to the QA/QC Department including objective setting, performance and** **attendance monitoring
- To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary.
- To complete appraisals for junior QA/QC staff as requested by the Head of Pharmaceutical Quality.
- To manage staff under the Trust Sickness and Rehabilitation process as requested by the Head of Pharmaceutical Quality.
**3.** **RESOURCE MANAGEMENT**:
- To assist in the planning for equipment procurement and ensure that equipment and plant is adequately qualified and maintained and its performance continuously verified.
**4.** **RESEARCH AND DEVELOPMENT (INCLUDING
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