Quality Assurance Pharmacist

Job summary There has never been a more exciting and innovative time to work within aseptic services at The Christie NHS Foundation Trust.
An excellent opportunity has become available for a technician with experience and interest in Aseptic Services.
You will be joining our dynamic aseptic team at an exciting and challenging time in developing a first-class aseptic service.
The aseptic unit is licensed and provides an extensive portfolio of Clinical Trials, including Phase 1 and Gene therapy, along with alongside Early Access Medicines and compassionate use schemes.
The unit is comprised of two cleanrooms, one dedicated to Gene therapy, with a total of five negative pressure isolators.
You will work closely with other members of our multi-disciplinary teams to ensure that Christie patients have access to the very latest developments in oncology and haematology medicines.
You will become an integral part of our aseptic service, clinical and research teams.
The Pharmacy Department is also supporting a number of collaborative projects alongside several research partners and has strong links with the University of Manchester.
Several members of our staff have undertaken post graduate training, research and other secondment opportunities and we are keen to support more.
Main duties of the job Have a look at this short video which outlines what it's like to work at The Christie ;ab_channel=TheChristieNHSFoundationTrust Working from home patterns within the department is in development.
About us The 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 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 description Job responsibilities DUTIES AND RESPONSIBILITIES Management To help plan, implement, maintain and evaluate operational aseptic services including staff, resources, activity, processes and information.
To identify, evaluate and implement new services, and improvements to existing services, when required in conjunction with the Aseptic Services Manager.
To promote good working relationships between all grades of staff.
To continually assess the service provided and to suggest improvements to ensure best practice is adopted at all times.
On a day to day basis communicate sometimes difficult and potentially contentious information back to the appropriate healthcare professionals.
To ensure effective, up to date standard operating procedures (SOPs) and processes are available within the Aseptic Services Unit which complies with national, regional and local guidance.
This will involve writing, authorising, implementing and reviewing SOPs on an ongoing basis.
To co-ordinate the use of unlicensed medicines across all areas of aseptic services including products purchased as specials.
To be involved in ensuring all equipment is validated and functioning correctly.
To be involved in ensuring all plant and equipment planned preventative and corrective maintenance is carried out.
To be involved in the management of the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation.
To liaise with Quality Control North West where appropriate to resolve any validation or monitoring issues.
To be involved in the management and effective resolution of customer complaints, product defects and recalls in adherence with Departmental, Trust, National and regional guidance.
To work within the Trust policies and procedures and be involved in the recruitment and retention of Aseptic Services staff.
To work within the Trust policies and procedures and be involved in the management and monitoring of Aseptic Services staff attendance, sickness and other absence, annual leave, study leave and career development.
To work within the Trust policies and procedures and take part in proceedings that may be required in disciplinary, grievance, fair treatment cases.
To liaise with pharmacy, medical and nursing staff in matters relating to aseptic services.
Involvement and organisation of Aseptic Services Management Team meetings, team meetings and QRM.
To be involved in ensuring that the Site Master File is updated and maintained.
To analyse data, write reports and present findings for publication and internal use when required.
To participate in and organise Bank Holiday and extended working.
To provide Bank Holiday and out of hours aseptic cover on a rota.
Leadership To act as a professional role model and develop positive relationships with key personnel.
To promote pharmacy services development within the Trust.
To be self-motivated and committed to the development of pharmacists, pharmacy technicians and support staff within your area of responsibility.
To represent the department at Divisional, Trust and external meetings as directed by the Aseptic Services Manager providing information and reporting back all relevant information to the appropriate staff.
Provide leadership and highly specialised advice on all matters relating to Aseptic Services activities.
Service Development To be involved in the contribution of specialist knowledge into the research and evaluation of new products, equipment, devices and methods of work, including clinical trials, analysing and interpreting the requirements for service developments within the Aseptic Services Unit.
To ensure validation is carried out for all service developments prior to introduction.
To be involved in ensuring that the Aseptic Services objectives are in line with Trust and departmental strategic development plans.
Along with the Aseptic Services Manager, be involved in the expansion of existing services and the development of other aseptic services in accordance with the departmental strategic plan.
To assist the Aseptic Services Manager in the monitoring and maintenance of the capacity plan, business cases and statements of need for products and services.
This will involve analysing data, writing reports and presenting findings.
Aseptic To be competent in the aseptic preparation of medicines.
To be involved in the Aseptic Verification process.
To supervise staff working in the ASU and to check the work in accordance with ASU procedures.
To be involved in ensuring the highest level of professional standards of service are provided from the Trust Aseptic Services Unit encompassing both quality and timeliness of service to patients and staff.
To perform, and instruct others to perform, complex dose calculations.
To act as a checker/product approver within Aseptic Services, checking the work of others members of staff in accordance with departmental procedures, throughout aseptic processing.
To help to ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment.
This involves strict hand washing procedures and changing into designated cleanroom clothing.
To ensure all documentation relating to the day to day operation of the ASU is completed correctly and reviewed at regular intervals.
To understand the key developments around the provision of patient care.
To be trained and registered to issue intrathecal doses.
To ensure cost effective use of resources within Aseptic Services to include the review and monitoring of the cleanroom clothing and cleaning / decontamination solution contracts To be involved in identifying required equipment and resources and manage the cost effective purchasing of aseptic services equipment, consumables and resources.
To be involved in the management of aseptic services stock ensuring stock levels.
To comply with legal and other requirements related to the purchase, supply, use, safe custody and destruction of medicines within pharmacy and other areas of the Trust.
To be involved in the monitoring of SACT waste and its reduction.
To be involved in the development and management of software systems ensuring they are risk assessed and validated.
Supervise the preparation of medicinal products made under section 10 of the medicines act 1968 and ensure compliance with Quality Assurance of Aseptic Preparation Services to provide products that are fit for their intended use, along with clinical trial preparations.
To coordinate with the senior technicians, the daily workload of medicines for injection to the wards and departments taking into account clinical priority, financial expediency and the capacity plan for the unit.
Ensure all production operations are carried out according to pre-established Standard Operating procedures and in accordance with Good Manufacturing Practice.
Responsible for the validation of the new pharmacy electronic worksheet system, in conjunction with the Aseptic Services Manager and their deputy.
Contribute to the development of products and services, with the Aseptic Services Manager and their deputy.
Liaise with the Aseptic Services Manager and their deputy for long term strategic development of Aseptic Services.
Assist with the support and running of the Pharmacy Quality Management System (QMS), internal and external audits.
Contribute to work on a business case for a new / significant refurbishment of the aseptic unit, and implementation of the resultant plans.
To be involved is the compilation and review of COSHH documents in line with any changes, and compliant with COSHH (1988) Regulations.
To be involved is the compilation and review of Stability documents in line with any changes.
Assist in ensuring the unit is fully compliant with the requirements of the executive letter EL(97)52 issued by the department of health.
Assist in ensuring the department is fully compliant with the requirements associated with the regulation of clinical trials.
To contribute to and participate in practise research initiatives within the department.
Policy To be involved in the compilation and review of Aseptic Services procedures in line with any changes in legal and ethical policy, Trust developments and local and regional guidance as well as departmental working arrangements.
To be involved in ensuring the adherence and upholding of Trust and departmental policies and procedures by the Aseptic Services staff.
To ensure confidentiality is maintained at all times.
Clinical Governance To ensure that Quality Assurance standards are maintained in accordance with national, regional and local requirements.
To assist the Aseptic Services Manager and their deputy in assigned audit activities and produce written reports and statistical information with identified action.
To be involved, along with the Aseptic Services Manager and their deputy, in ensuring that the annual validation activities are carried out.
To help to ensure staff within the ASU work within the policies and procedures in order to provide a safe, efficient, patient centred aseptic service.
To help to ensure that all quality exceptions are documented and appropriate action is taken to resolve any issues raised.
To assist the Aseptic Services Manager and their deputy to maintain systems which monitor, evaluate and report aseptic service errors and incidents and implement effective CAPAs.
To be involved in ensuring the aseptic services support the developments of other pharmacy services and comply with relevant statutory and ethical guidance by taking an active role in departmental meetings.
Ensure appropriate change control processes are followed and authorise changes to any existing product/process or the implementation of any new product or process.
Person Specification Qualifications Essential Masters Degree in Pharmacy Registered with the General Pharmaceutical Council (Pharmacist).
Evidence of up to date CPD Desirable Postgraduate diploma in clinical pharmacy Pharmaceutical Technology and Quality Assurance Experience Essential Extensive post qualification experience in hospital pharmacy with specialist knowledge of working in aseptic services.
Specialist theoretical knowledge of Aseptic Technical Services.
Specialist aseptic services knowledge relating to: -Legislation -NHS, local and National guidance -EL(97)52 Audit Experience of writing and developing SOPs Desirable Experience working with clinical trials within an aseptic environment.
Experience dealing with external agencies.
Experience of staff training and development Skills Essential Ability to liaise with senior Trust managers.
Leadership skills with ability to set and meet deadlines.
Ability to work on own initiative, under pressure and with excellent time management and organisational skills.
Ability to deal with difficult situations and staff.
Flexible and adaptable.
Ability to process complex information and develop reports.
Ability to relate to all grades of staff and patients.
Professional awareness Good communication skills, written and verbal, with ability to demonstrate fluency, clarity and effectiveness at all levels.
Good negotiating skills.
Can remain composed and effective in demanding situations.
Can reflect and critically analyse own performance.
Good computer literacy.
Able to identify, prioritise and solve problems.
Committed to developing and extending pharmacy services.
Able to critically evaluate evidence.
Able to implement change.
Able to work effectively with senior medical and trust managerial staff.
Ability to deal with difficult situations and staff.
Professional awareness Desirable Well-developed teaching and presentation skills.
Experience of staff and service development skills.
Ability to manage and co-ordinate difficult organisational change.
Knowledge Essential Knowledge of pharmacy computer systems.
Knowledge of HR policies and procedures.
Experience of appraisals Experienced in use of Microsoft Desirable Knowledge of budget setting and management Values Essential Professional Extremely flexible and reliable Strong commitment to the values of The Christie NHS Foundation Trust.
Other Essential Involvement in Saturday, Bank Holiday and On Call working.