Highly Specialist Aseptic Services Technician

Highly Specialist Aseptic Services TechnicianThere has never been a more exciting and innovative time to work in our Aseptic services team. An excellent opportunity has become available for a technician with experience and interest in Aseptic Services & Research.The Aseptic Services Unit at the Christie NHS Trust is a world leader in the production of phase one clinical trial materials. We prepare an extensive portfolio of hundreds of Clinical Trials alongside Early Access Medicines, Free of Charge products and Compassionate use schemes.The suitable applicant should be highly motivated and show accurate attention to detail. They should be organised and able to prioritise work effectively showing excellent interpersonal and communication skills.The successful candidate will become part of our dynamic and fast paced team who are truly dedicated to creating products that help treat patients with cancer. They will participate in and supervise the Aseptic production of Clinical trials, SACT, EAMS, FOC and Gene therapy injectable medicines in one of our dedicated cleanrooms housing a total five negative pressure isolators. They will be responsible for the day to day running of the unlicensed production unit, managing staff, training, stock, HR duties and Quality Assurance.Main duties of the jobThe successful applicant will be part of dynamic and fast paced team. Their key role will be to assist the Chief Aseptic Technicians in managing the aseptic preparation services of the pharmacy department under the professional direction of the Aseptic Services Manager and Deputy Aseptic Services Manager.This will be achieved by:o Involvement with the Clinical Trial portfolio within Aseptic Services, including R&I reviewo Supervision and management of technical staff, including HR duties eg: PDRs, return to worko Organising the safe and efficient production of aseptically prepared productso Delivering full training to production staff taking part in GMP activities, ensuring proficient and safe working within an Aseptic Services Unito Supporting co-ordination of operator validations and competency checkso Co-ordinating workflow and workforce, ensuring a safe, efficient and effective service to the trust and patientso Revision of Standard Operating Procedures and implementation of new or revised procedureso Managing cost effective use of consumables and sanitisation products used within the aseptic facilityo Taking part in internal and external auditso Supporting investigations related to events in production, carrying out Quality Assurance tasks.About usThe Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.Job responsibilitiesSpecific Responsibilities1. Management Responsibilities - Aseptic Services1.1 Assists in the management and development of the technical element of the aseptic service to maintain a safe, efficient and effective service. Ensures that safe systems of work as agreed locally are followed at all times.1.2 Assists the Head of Production in the direct operational organisation and management of the following aspects of Aseptic Services:-i) Intravenous additivesii) Cytotoxic productsiii) Intrathecal injectionsiv) Clinical trials/ investigational materialsv) Any other special aseptic manipulations which may be required1.3 Responsible for organising and managing the daily workload planning and staff utilisation within the aseptic unit, including personal participation as required, and delegates duties to technicians and assistants so that departmental objectives are achieved.1.4 Is responsible for ensuring that that the aseptic service complies with clinical governance strategies including risk management assessments of working practices, reporting of clinical incidents, pharmacy error reporting schemes, intervention monitoring and risk reduction strategies.1.5 Provides cover for the aseptic staff management and workload responsibilities of the Chief Pharmacy Technician Aseptic Services when absent.1.6 Maintains the environmental standards within the Aseptic Service facilities to regional and national standards.1.7 Ensures all monitoring is completed according to procedures and guidance, perform preliminary investigation then report any deviations/ omissions or problems.1.8 Ensures that professional and quality standards comply at all times with:i) Rules & guidance for manufacturers of medicinal products (Orange Guide).ii) Local and regional quality initiatives.iii) The Farwell Report iv) The requirements of the Royal Pharmaceutical Society of Great Britain.v) The requirements of the National Health Service Executive.vi) The requirements of the Medicines and Healthcare Regulatory Agency Control Agencyvii) The Quality Assurance of Aseptic Preparation1.9 Contributes to the review system for Standard Operating Procedures (SOPs) and worksheets and ensure implementation of any new / changed procedures.1.10 Ensures that an efficient aseptic dispensing and distribution service is provided to patients and staff which is in line with current standards and conforms to agreed service deadlines within the service level.1.11 Receives, assesses and initially investigates any complaints, referring to senior colleagues as necessary1.12 Ensures that all operational practices, procedures, records and financial controls comply with applicable legislation such as the Medicines Act, the Misuse of Drugs Act, Health & Safety at Work Act, the Control of Substances Hazardous to Health Regulations and local procedures.1.13 Is trained and named on the intrathecal register to undertake appropriate preparation and documentation tasks relating to intrathecal chemotherapy services.1.14 Ensures and promotes the safe handling and preparation of cytotoxic drugs. Responsible for training of technical staff in this area.1.15 Participates in the production of all types of aseptically prepared products demonstrating the necessary high standard of dexterity, accuracy and precision required for aseptic manipulations1.16 Ensures that all appropriate information is communicated effectively to all aseptic staff and customers, and to other pharmacy staff where appropriate.1.17 Manages the stock for all products used in Aseptic Services.1.18 Participates in internal audits and external audits from both Regional Quality Control and MHRA, if applicable.1.19 Participates in the preparation of the remedial action plan in response to these audits and ensures the plan is delivered.1.20 Maintains an annual schedule of operator validation testing to ensure all staff involved in aseptic work hold a current authorised test pass.1.21 Pro-actively identifies and initiates improvements and developments to working practices, procedures and documentation.1.22 Ensures the completion of workload statistics as required.1.23 In the case of equipment/ air handling failure, takes responsibility for initiating the immediate action and reporting.1.24 Be a main contributor to the training of staff in aseptic technique and daily organisation, demonstrating the high levels of dexterity and accuracy required.1.25 Liaises with other hospitals within the trust to provide a cohesive aseptic service on a daily basis.1.26 Ensures that all items used in aseptic and extemporaneous dispensing procedures are recorded as costed issues.1.27 Performs in-process checks on the work of Aseptic Technical Staff and ATOs in accordance with the safe systems of work as laid down in the SOPs. 1.28 Acts as a super-user to the pharmacy computer and temperature monitoring system, trouble-shooting, error-logging, and escalating issues as necessary.1.29 Performs final check for unlicensed products prepared under section 10 exemption as per accreditation under the National Framework for product approval. Must be qualified to do so or be working towards qualification.1.30 If qualified, performs Product Approval for unlicensed products prepared under section 10 exemption as per accreditation under the National Framework for product approval.2 Staff Management2.1 Directly supervises the workload of the Aseptic Technical staff by directing and allocating work as appropriate. Ensures that appropriate technical grades of staff are available to cover all areas as required.2.2 Works closely with the Chief Pharmacy Technician Aseptic Services, Senior Technicians and pharmacists to develop an integrated service built around flexible attitudes and teamwork.2.3 Agrees Personal Development Plans for staff who are in permanent line management relationships with the post holder and for technicians and assistants as part of the appraisal cascade.2.4 Predict or identify fluctuations in staffing levels to ensure there are no interruptions to the supply service. This includes maintaining service provision during periods of unanticipated sickness absence.2.5 Participates in the recruitment and selection of technical staff.2.6 Contributes to the development and management of changes in the delivery of pharmacy services in line with departmental and corporate strategy.2.7 Undertakes return to work interviews with technical staff in line with Trust procedures.2.8 Ensures that staff in training are supervised at all times in line with Trust or nationally approved programmes.2.9 Promotes safe standards of care and service and participate in clinical governance issues such as CPD, clinical effectiveness and audit, and risk management.3 Equipment and Supplies3.1 Ensures the cost-effective use of equipment, consumable supplies and medicines.3.2 Maintains adequate and appropriate stocks of both medicines and consumables used in the unit ensuring stock rotation and delivering any information requested on purchase, usage or stock levels.3.3 Ensures the safe and appropriate storage of all medicines and consumables ensuring all required records are maintained.3.4 Monitors the equipment, reports any faults or damage and ensures timely maintenance and repairs.3.5 Liaises with any contractors where necessary, ensuring such personnel follow the required clean room practices.4 General Duties4.1 Participates in late night rota, Bank Holiday and weekend rotas within ASU.4.2 Participates in teaching inside and outside the department to pharmacy staff and other disciplines including non-pharmacy staff visiting the department.4.3 Participates in the Trusts adverse incident reporting and review system by identifying and reporting adverse incidents so that lessons can be learnt and shared to promote improvements.4.4 To keep abreast of current pharmaceutical practice and knowledge with particular reference to those areas for which he/she has responsibility.4.5 Undertakes CPD and completes all necessary requirements for GPhC re-validation.Person SpecificationQualificationsBTEC National Certificate in Pharmacy Services NVQ level 3 in Pharmacy Services, Aseptic Pharmaceuticals Science Manufacturing Technician level 3 or recognised equivalentRegistered technician with appropriate professional body. Evidence of up to date CPDBTEC Professional Diploma - Final Accuracy Checking within Technical Services, or willingness to completeManagement qualification to diploma level or equivalent experience.Product Approval Accreditation Programme (PAAP) Qualification, or willingness to completeExperienceSubstantial post qualification experience of working in Aseptic ServicesSpecific aseptic experience and external/internal audit experience.Experience of writing and developing SOPsExperience of staff training and developmentSpecialist theoretical knowledge of Aseptic Technical ServicesStaff managementRecruitment & selectionExperience of aseptic services audits and inspectionsSkillsOrganisational abilityAbility to work under pressureAbility to work on own initiative & as part of a teamTeaching/training & mentoringLeadership abilityAuditAble to manage changeKnowledgeExcellent working knowledge of current pharmacy practiceGood pharmacological knowledge of frequently used drugs Understanding of GMP(good manufacturing practice)Stock Control SystemsHealth & Safety issues (Pharmacy ProcurementPersonal AttributesExcellent communication & interpersonal skillsExcellent organisational skillsAbility to prioritise work effectivelyAbility to lead and motivate othersAbility to train and develop staffProfessionalExtremely flexible and reliableAbility to work to deadlinesValuesAbility to demonstrate the organisational values and behavioursDisclosure and Barring Service CheckThis post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.£38,682 to £46,580 a yearPer annum, Pro rata #J-18808-Ljbffr