Lead Pharmacist Aseptic Services (Interim)

Job description

Job responsibilities

Leadership and Management

1. To lead, direct and support the PASU Team to ensure the provision of a safe, high quality, comprehensive and cost efficient aseptic service to the Trust.
2. To work collaboratively with external contractors and to be a representative of the Trust as an End User to deliver facilities or equipment in line with User Requirement Specifications.
3. To be responsible for assuring the PASU facility is compliant to standards for an unlicensed Aseptic Unit operating unfder Section 10
4. To be responsible for providing professional supervision in aseptics and adherence to the requirements of operating an aseptic unit under section 10 exemption of the Medicines Act 1968.
5. To be responsible for the qualification, commissioning and validation of new aseptic service facilities and equipment.
6. Responsible for ensuring the PASU has robust Planned Preventative Maintenance including integrating with Trust Estates and Facilities Management teams to assure the operation of the facility to national standards.
7. To be responsible for ensuring staff are adequately trained in the safe operation of equipment and facilities of PASU.
8. To oversee the delivery of electronic systems used by PASU including the new JAC Aseptic preparation module for generation of worksheets, labels and including overseeing the validation of the system and associated procedures.
9. To ensure completion, review and compliance to the PASU Validation Master Plan.
10. To contribute to operational effectiveness of the running of PASU, including supervising the aseptic process and product final check & release of finished products for use.
11. To be responsible for ensuring the service is fully compliant with the relevant regulatory guidelines and legislation including Health and Safety, COSHH
12. To be responsible for approval of all Pharmaceutical Quality Systems of work and documentation to ensure compliance with the Quality Assurance of Aseptic Preparation Services (QAAPS) standards and Rules and Guidance for Pharmaceutical Manufacturers and Distributors (EC Guide to Good Manufacturing Practice).
13. To work with the Pharmacy Quality Assurance Lead to ensure that environmental monitoring is carried out in line with national standards and that results are monitored/analysed with set action levels, in order that any deviations from standards or quality exceptions are managed appropriately using CAPA and Change Control principles.
14. To oversee the delivery of a robust Contamination Control Strategy in line with the requirements of EU GMP Annex 1.
15. To provide expert advice to the Trust on safe systems of working including handling of aseptically prepared products, management of cytotoxic spills and waste management of cytotoxic drugs.
16. Provide expert advice to clinicians, nursing personnel and other healthcare professionals regarding the prescribing, preparation and administration of these highly complex pharmaceutical doses and assist ward staff in the event of non-availability of the Aseptic Unit or capacity issues.
17. To provide highly complex technical information and expert advice on complex high-risk injectable medicine quality related issues where requested such as stability assessments and suitability.
18. To deliver the strategic development of the Trusts aseptic service in order to meet both current and future service needs, Trust priorities, the Cancer Strategy and wider NHSE strategy on productivity, efficiency and care quality.
19. Leading on delivery of regulatory compliance in relation to iQAAPs and the Key Quality Indicators for service performance and status and responsible for delivering on any actions to improve service.
20. To be the Trust lead for aseptic services for external (EL97, 52) audit of the aseptic unit and to action any deficiencies identified, and responsible for ensuring internal QA audits in aseptic services are performed.
21. To be responsible for a capacity plan and contingency arrangements are in place to maintain safe operating standards for current and future workload in aseptic services and to use appropriately to escalate risk of service within pharmacy and to Trust stakeholders.
22. To identify resources required, produce and implement business plans to optimise service delivery to meet the needs of the patients and other service users. This will include human resource / workforce plan, facilities and equipment planning.
23. Develop and maintain effective working relationships with colleagues and key stakeholders across departmental and organisational boundaries including collaborative working with colleagues in the Bath and North East Somerset, Swindon and Wiltshire Integrated Care System
24. To contribute to regional technical services meetings to develop best practice and to input into a regional strategy for providing aseptic products.

Governance

1. To act as the Accountable Pharmacist (as defined in the Quality Assurance of Aseptic Preparation Services standards), and professional lead for the PASU taking responsibility for all aspects of the service.
2. To ensure risks are managed within PASU, and that any risks identified are systematically highlighted and reviewed using Trust risk management policies and procedures.
3. To ensure that a strategy is in place to reduce risk, and that risk assessments are approved by the Pharmacy Senior Leadership Team.
4. To critically evaluate and sign off procedures and key documentation within PASUs Pharmaceutical Quality System to ensure best practice is promoted within all aspects of aseptic services including regular auditing in line with the Quality Assurance of Aseptic Preparation Services standards.
5. To ensure PASU compliance in accordance with current National Guidance and GWH policy on the Safe Administration of Intrathecal Chemotherapy.
6. To ensure that the resolution of quality exceptions, incidents and complaints is undertaken and completed in a timely manner in accordance with the Quality System and is documented and trended appropriately.
7. To report into Pharmacy Senior Leadership Team for discuss and/or escalation of quality and risk related issues, present procedures for formal departmental approval, and provide a progress update on audit action plans.
8. Responsible for overseeing delivery of performance reporting for aseptic services and produce reports internally for Pharmacy and externally to Division and Board.
9. To regularly present complex reports and briefings for directors and key stakeholders relating to risk, error rates, performance and progression of service improvements and to give assurance on their controls and mitigation
10. To support the responsible person and deputies in ensuring that the facilities and service are compliant with all aspects of GxP and all other relevant medicines regulations e.g. GDP, GCP, WDA.
11. To ensure compliance with Good Clinical Practice (GCP) for aseptic clinical trials involving medicinal products. Co-ordinate with the Trust research team in the setting up and running of clinical trials involving aseptically prepared drugs.

Responsibilities for People or Training

1. To approve the training for pharmacists, pre-registration pharmacists, technical and assistant staff within aseptic services, so that they are equipped with the skills and competencies required to provide a safe and effective service to the recognised standards.
2. Responsible for the day to day range of staff management matters, which will include responsibility for supporting appraisals, development of staff, performance, recruitment and where necessary processes such as grievance and disciplinary matters.
3. To ensure that the GMP competency-based training for all staff is maintained and developed and that individual training records are complete and up to date.
4. To contribute to general pharmacy education, training and assessments for Pharmacists, Pre-Registration Pharmacists, other Pharmacy, Nursing and Medical staff.
5. Identify personal training and development needs through the appraisal & personal development planning process.
6. To maintain a portfolio of practice and Continuing Professional Development (CPD) that meets the General Pharmaceutical Councils (GPhC) requirements.

Financial Responsibilities

1. Responsible for ensuring the budget relating to Aseptic Services pay and non-pay e.g. staff, consumables and drug expenditure is accurate and managed including identification and escalation of causes and potential impact of over-spend.
2. To work with procurement, regional frameworks and external Specials Manufacturers to ensure the Trust is receiving best value for money in relation to expenditure and service for both consumables, ready to administer parenteral drugs and technical services.
3. To work with and be responsible for accurate reporting to service commissioning bodies such as NHSE specialised commissioning.
4. Constantly strive for value for money and greater efficiency in the use of these budgets and to ensure that they operate in recurrent financial balance year on year.
5. Act in a way that is compliant with Standing Orders and Standing Financial Instructions in the discharge of this responsibility.

Other Factors

1. To maintain a broad level of Pharmacy practice.
2. There is a requirement to participate in Bank Holiday and weekend working as well as late duty on a rotational basis.

Flexibility

This job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances, in discussion with the post holder. This role profile is intended to provide a broad outline of the main responsibilities only. The post holder will need to be flexible in developing the role with initial and on-going discussions with the designated manager.

Person Specification

Qualifications

Essential

• oPharmacy Degree oDiploma/MSc in technical services / quality assurance or equivalent experience oRegistered Pharmacist with the General Pharmaceutical Council oKeeping professionally up to date including CPD oLeadership skills / qualification

Desirable

• oEvidence of training in change management oProject management qualification oQualification in healthcare leadership

Experience

Essential

• oSignificant experience working in hospital pharmacy oExtensive experience in hospital aseptic services. oExperience of managing staff oExperience of process re-design and strategic capacity planning oEvidence of implementing major change and change management processes. oExperience of working across departmental and organisation boundaries to deliver specific targets and improve services for patients.

Desirable

• oExperience of managing an aseptic service oExperience of leading and developing a service oExperience and good understanding of ICH GCP, the EU Directives and UK Regulations that relate to clinical trials. oProject management experience oExperience of leading on business plan developments with deliverable outcomes. oExperience of managing a finance budget

Knowledge

Essential

• oKnowledge of regulatory and licensing controls related to Pharmacy Aseptic Services oAdvanced technical knowledge across a variety of aseptic services oIn depth knowledge and understanding of all aspects of GMP and QA. oIn depth knowledge and understanding of commissioning of pharmacy aseptic services oProven ability to maintain, develop and maintain a pharmaceutical quality system oDealing with distressed patients/clients regularly oDealing with security concerns, legal, professional issues oDealing with incidents, complaints oRegular VDU usage oExposure to hazardous materials such as cytotoxics oAbility to concentrate on complex/demanding tasks, frequent interruptions oRegular late working, or on call by negotiation oExcellent communication skills - verbal and written e.g. SOPs & reports oProvide highly complex technical information, expert advice and reports for key stakeholders oAble to prioritise on workload, delegate appropriately and manage time effectively oGood IT skills (Excel, Word and PowerPoint)

Desirable

• oAbility to provide a strategic vision for aseptic services

Skills

Essential

• oSelf-directing oPositive, enthusiastic and able to demonstrate visionary thinking oAble to work under pressure and with variable demands oDiplomatic oWorks well in multidisciplinary teams oOrganisational awareness oDeals calmly and appropriately with emotional situations related to complaints, incidents oRequired to drive oWilling to work in other areas of the Trust or Trust-wide as and when required to do so.

Disclosure and Barring Service Check

This 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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Great Western Hospitals NHS Foundation Trust

Address

Great Western Hospital

Marlborough Road

Swindon

SN3 6BB

Employer's website

https://www.gwh.nhs.uk/ (Opens in a new tab)