Advertised role location: PLENUM BUILDING
Official document: Band 8D_Lead Pharmacist, Regional Pharmaceutical Quality Assuran (doc)
JOB DESCRIPTION

POST: Lead Pharmacist Regional Pharmaceutical Quality Assurance Service

LOCATION: Pharmacy Services Belfast Trust, The Plenum Building

BAND: 8D

REPORTS TO: Professional Manager Pharmacy Services (Deputy Head of Pharmacy) Medicines Procurement and Regional

RESPONSIBLE TO: Pharmacy Manufacturing Services
Head of Pharmacy & Medicines Management

Job Summary / Main Purpose

Victoria Pharmaceuticals

The post holder will be named on the MHRA Specials licence (MS32485) as the person responsible for Quality Control for Victoria Pharmaceuticals Site Location 1683129 as detailed in the EU Guide to Good Manufacturing Practice (GMP). Consequently the post holder will lead on the quality assurance and pharmaceutical quality system elements of all activity under licence at this site which includes sterile manufacturing by filtration, non sterile manufacturing, and over labelling and repacking of medicines. The post holder will lead manage and develop RPQAS staff to meet the quality assurance and pharmaceutical quality system demands of Victoria Pharmaceuticals, Plenum Building.

The post holder will be named on the Investigational Medicinal Products Licence MIA(IMP) 32485 as the person responsible for Quality Control. In addition the post holder may formally deputise for the Responsible Person under the wholesale distribution authorisation WDA(H) 32485.

Reporting to the Professional Manager Pharmacy Services, the post holder will be responsible for security and health and safety in all of the Plenum Building and will be responsible for ensuring completion of the all statutory and Trust health and safety monitoring returns for both Victoria Pharmaceuticals and the Regional Pharmaceutical Quality Assurance Service.

Northern Ireland Health and Social Care Trusts

The post holder is responsible for the strategic development, leadership and management of the Regional Pharmaceutical Quality Assurance Service (RPQAS) for Northern Ireland which is based in BHSCT.

The post holder will be responsible for the compliance management in respect of the Northern Ireland Guidance for the Assurance of Aseptic Preparation of Medicines for Section 10 Aseptic Units and may be required to be an accredited national aseptic auditor for the auditing of aseptic units depending on his/her capacity.

The post holder will lead the service that provides a range of tests, audits and controls and undertakes comprehensive analytical and microbiological monitoring of products using pharmacopoeia and other validated methods to ensure that when referred, pharmaceuticals purchased by or prepared by the hospital service in Northern Ireland are of high quality and meet the appropriate standards.

The post holder is responsible for ensuring RPQAS provide an ongoing advice service on pharmaceutical quality control and pharmaceutical quality assurance to Belfast Health and Social Care Trust and South Eastern Health and Social Care Trust pharmacy services, as well as to the wider HSC as necessary.

Main Duties, Responsibilities and Leadership
For each of the following, the postholder will;

Victoria Pharmaceuticals
The post holder will be named on the MHRA Specials licence (MS32485) as the person responsible for Quality Control for Victoria Pharmaceuticals Site Location 1683129 as detailed in the EU Guide to Good Manufacturing Practice (GMP). Consequently the post holder will lead on the quality assurance and pharmaceutical quality system elements of all activity under licence at this site which includes sterile manufacturing by filtration, non sterile manufacturing, and over labelling and repacking of medicines. The post holder will lead manage and develop RPQAS staff to meet the quality assurance and pharmaceutical quality system demands of Victoria Pharmaceuticals, Plenum Building.
Agree formally on an annual basis with periodic review, key performance objectives and delivery indicators with the Professional Manager Pharmacy Services relating to both the regional and Victoria Pharmaceuticals (VP) element of the job.
Agree with the Production Manager, VP Plenum, a service level agreement for quality assurance services to Victoria Pharmaceuticals that meet their regular portfolio demand and service development portfolio. This will be jointly approved by the Regional QA Pharmacist, Production Manager, VP Plenum, and Professional Manager Pharmacy Services.
Report formally bimonthly to the Professional Manager Pharmacy Services on resource utilisation and capacity demands within RPQAS relating to Victoria Pharmaceuticals, Regional and BHSCT workload. To ensure, document and report to the Professional Manager Pharmacy Services safe mitigation when demand exceeds capacity on a recurring (non ad hoc) basis.
Lead jointly with the Production Managers (VP Plenum and VPKBN) and the named quality control pharmacist for Victoria Pharmaceuticals, Knockbracken (VPKBN) site for MS32485 in the digitalisation of the pharmaceutical quality system within Victoria Pharmaceuticals.
Implement and maintain Good Laboratory Practice by ensuring periodic review of staff job descriptions and personnel specifications and qualifications to meet future service demands and needs. To implement and inculcate a continual culture of learning and development.
Be the equipment controller for RPQAS with appropriate delegation and to ensure that equipment and plant is safe, adequately maintained and validated to meet the needs of Victoria Pharmaceuticals finished product testing, sterility testing and environmental testing.
Chair the bimonthly pharmaceutical quality system meeting for Victoria Pharmaceuticals and ensure the named quality assurance pharmacist on the VPKBN site for MS 32485 is given the necessary training and resource to deliver the same at VPKBN senior business/PQS meeting.
Establish, monitor and review quality assurance and production procedures.
Prepare, approve, monitor, review and update specifications for starting materials, finished products, packaging materials and labels.
Monitor, review and approve manufacturing documents and procedures ensuring compliance with the Guide to Good Manufacturing Practice and current legislation.
Monitor and review analytical methods for carrying out tests and analyses ensuring currency of all procedures.
Be responsible for the PCSS cleaning and environmental monitoring in the Plenum Building. To establish and implement procedures for cleaning , evidence of cleaning and environmental monitoring in the Plenum Building. This may be delegated within RPQAS.

Northern Ireland Health and Social Care Trusts
Advise the Heads of Pharmacy and the Chief Pharmaceutical Officer (CPO) for Northern Ireland on policy with regard to quality assurance, quality control with respect to medicines, medicines preparation, dispensing and manufacturing.
Ensure that audits are performed and to undertake audits, as necessary, at the prescribed intervals, of all Aseptic Dispensing facilities in Northern Ireland in accordance with the requirement of The Department of Health and to make recommendations with regard to their fitness for purpose.
Contribute to the planning and design of production and aseptic preparation facilities across Northern Ireland HSC Pharmacy Services.
Advise the Belfast Trust Head of Pharmacy on resource needs for quality assurance services across Northern Ireland HSC Pharmacy Services.
Ensure that RPQAS are represented at the appropriate level at the Regional Standing Group for Contract Evaluation (SGCE) for tender processes, contracts and frameworks relating to the selection of medicines including unlicensed medicines.
Represent Northern Ireland on the NHS Pharmaceutical Quality Assurance Committee.
Lead the Regional Quality Assurance Working Group.
Ensure representation from RPQAS on the Northern Ireland Regional HSC Trust Aseptic Group.
Ensure RPQAS representation on other regional groups as required by the Belfast Trust Head of Pharmacy, Professional Manager Pharmacy Services and Chief Pharmaceutical Officer.
Ensure RPQAS representation in regional training initiatives for manufacturing, aseptic preparation, dispensing, quality control and quality assurance.
Participate and initiate investigations relating to stability and shelf life of products manufactured both locally and regionally in Northern Ireland.

Provide and manage a medical gas testing service for the Belfast and South Eastern Trusts which also includes a regional emergency cover outside normal working hours. The post holder will be required to participate in either the regional emergency cover rota or the alarm response rota for Plenum and VPKBN, as agreed with the Professional Manager Pharmacy Services.
Assess the quality of unlicensed medicines supplied from outside the Trust and provide recommendations in relation to their use.

Strategic Management
Provide professional advice and support on strategic developments with respect to pharmaceutical quality assurance within and outside the Trust, ensuring they link with local and national strategies.
Be responsible for initiating and developing policies within the Trust across a range of areas.
Interpret legislation and associated guidance on pharmaceutical quality assurance for the Region and resolve any conflicting regulatory issues to ensure good clinical practice and patient care.
Be responsible for strategic development of RPQAS and ensuring that developments are resourced properly.
Contribute to the overall vision, strategic direction and operational performance with respect to pharmacy staff within pharmacy and medicines management in BHSCT.
Support pharmacy staff with opportunities to develop leadership roles and take individual and collective responsibility for the delivery of safe, effective and high quality care.
Demonstrate and exemplify positive behaviours and attitudes, acting as a role model to others and so contributing to the development of future pharmacy leaders.
Prepare resource bids and business plans for presentation and dissemination to service commissioners.

Governance, Safety and Excellence
Promote the values and cultures of the organisation through the development and implementation of relevant policies and procedures.
Use BHSCT organisational datix and risk register as a guide to open and transparent reporting of incidents that are either internal or have an internal origin in RPQAS which has impacted on service delivery or reputation.
Contribute to the quality controls and quality assurance processes to ensure high quality, safe and effective service delivery.
Ensure that patient centred care underpins the delivery of safe, effective, high quality, compassionate patient care.
Ensure that learning from serious adverse incidents (SAIs). Incidents, complaints, risk identification and assessment, external quality monitoring reports and litigation is disseminated and embedded into practice.
Monitor service delivery and ensure that a safe effective level of service is provided within allocated resources, and in line with Pharmacy Management Plan and any service level agreements with service users.
Ensure that examples of excellence and innovation in areas of responsibility are promoted within the service, within the Trust and externally through networking and contribution to workshops and conferences.

Ensure capacity within RPQAS pharmacists to support pharmacy and wider Trust in the assessment of medicines that potentially the Trust may decide to increase shelf life under risk assessment to meet an acute clinical demand. This may involve interpretation and professional advice on physical, chemical and microbiological data at a point in time.
Be the responsible officer within RPQAS for the safe management of handling of controlled drugs (S2-5) within the service and to ensure RPQAS participation the undertaking of controlled audits between RPQAS, VP Plenum and VP KBN.
Ensure any incidents relating to controlled drugs are reported within RPQAS and if necessary to the Professional Manager Pharmacy Services if unresolved within 24 working hours.
Be responsible for security and health and safety in all of the Plenum Building and will be responsible for ensuring completion of the all statutory and Trust health and safety monitoring returns for both Victoria Pharmaceuticals and the Regional Pharmaceutical Quality Assurance Service, including BRAAT.

Collaborative Working
Work in partnership with key stakeholders, within and external to the organisation, to meet organisational objectives and HSC transformational goals where conflicting agendas may arise.
Establish collaborative relationships and networks with external stakeholders.
Engage with regional organisations and professional bodies to secure positive working relationships.

Quality, Innovation and Development
Be responsible for being trained in Good Clinical Practice (GCP) and have knowledge of the UK Policy Framework for Health and Social Care Research.
Lead and participate in a comprehensive program of practice research and in-service audit.
Critically appraise Regional Pharmaceutical Quality Assurance Service identify gaps in the evidence base, and subsequently undertake/publish own practice research and enable team members to do likewise.

Communication and Information Resources
Implement organisational change ensuring effective communication with staff and patients/users/relatives.
Contribute to the development of informatics and technology to support the redesign and development of aseptic services.
Display a personal commitment to collaborative team working across disciplines, specialities, teams and groups to develop and maintain effective partnership working within a management structure which supports patient centred outcomes rather than service driven line management processes.
Establish and maintain positive interpersonal relationships with other staff members characterised by trust, mutual respect and open, honest communication.
Identify information needs and data requirements to support RPQAS workforce development, including pharmacy KPIs.
Ensure decision making is informed by appropriate data analysis and interpretation and to use these to provide expert guidance to the organisation, to formulate strategic plans and to make decisions that shape service development and delivery across the trust.
Undertake detailed benchmarking analysis /comparative work to assess the positioning and delivery of aseptic services.
Lead the coordination of information and documentation of aseptic pharmacy activities and provide reports to the Head of Pharmacy, Director of Surgery & Specialist services and other directors as required including SPPG.

Financial and Resource Management
Be responsible for the management of all Regional Pharmaceutical Quality Assurance Service budgets. This includes staffing, goods and services and income.
Ensure good financial control is maintained and all financial targets are met.
Develop and monitor appropriate controls within scope of responsibility in accordance with the trusts schedule of delegated responsibility.
Support PET in the delivery of the Trust’s strategic and operational business plans.
Assist the Head of Pharmacy and Medicines Management and the Professional Manager Pharmacy Services to ensure that an adequate allocation of staff from resources available is deployed across operational areas so professional standards and patient and client requirements and experience are maintained.
Be an authorised officer included on the Trust's Authorisation Framework for requisitioning, authorising and receipting goods and services.
Adhere to agreed policies and procedures including standing financial instructions.
Ensure the trusts funds are effectively used, that financial commitments represent value for money and comply with standing financial instructions and trust protocols.

Professional, People Management and Development
Promote lifelong learning within the wider RPQAS team by leading on the development and commissioning of education programmes required to support current role development and new and emerging pharmacist, pharmacy technician and support staff roles.
Participate in the Trust’s Staff Development Review Scheme for relevant staff and advise on appropriate further training.
Promote succession planning within RPQAS.
Complete Trust recruitment requisitions and chair interview and selection panels.
Identify training needs of pharmacy staff, including induction, mandatory update and developmental training, in order to embed excellent practice within pharmacy services.
Participate in the provision of specialist education and training for pharmacy, medical, nursing and allied health professional staff.
Ensure that pre-registration pharmacists, student pharmacy technicians, visiting undergraduate students and work experience students working in Adult Haematology and Oncology undergo appropriate induction and training programmes with documented assessments and defined competencies.
Participate in relevant continuing postgraduate education, training and professional development.

General Requirements
Undertake other duties as may be assigned to you from time to time.
Maintain required standards of appearance and dress.
Undertake keyholder duties/ fridge monitoring response and on call for alarms. The post holder if on the on call rota for alarms must be able to respond on site.
The post holder will be expected to participate in life-long learning, maintain awareness of current practice, a current CPD Portfolio and attend such courses and training as may be deemed necessary by the Professional Manager Pharmacy Services.

The duties and responsibilities outlined in this job description are neither meant to be definitive nor restrictive and may be modified to meet changing needs. It should be noted therefore that duties, designation and location of post might be subject to change in the future to meet the changing requirements of the service.

General Responsibilities

Employees of the Trust are required to promote and support the mission and vision of the service for which they are responsible and:

At all times provide a caring service and to treat those with whom they come into contact in a courteous and respectful manner.
Demonstrate their commitment by their regular attendance and the efficient completion of all tasks allocated to them.
Comply with the Trust’s Smoke Free Policy.
Carry out their duties and responsibilities in compliance with the Health and Safety Policies and Statutory Regulations.
Adhere to Equality and Good Relations duties throughout the course of their employment.
Ensure the ongoing confidence of the public in-service provision.
Maintain high standards of personal accountability.
Comply with the HPSS Code of Conduct.
The post holder will promote and support effective team working, fostering a culture of openness and transparency. The post holder will ensure that they take all concerns raised with them seriously and act in accordance with Belfast Trust’s Whistleblowing Policy and their professional code of conduct, where applicable.
The post holder will, in the event of a concern being raised with them, ensure it is managed correctly under the Belfast Trust’s Whistleblowing Policy, and ensure that feedback/learning is communicated at individual, team and organisational level regarding the concerns raised, and how they were resolved.

Information Governance  

All employees of Belfast Health & Social Care Trust are legally responsible for all records held, created or used as part of their business within the Belfast Health and Social Care Trust, including patient/client, corporate and administrative records whether paper based or electronic and also including e-mails.  All such records are public records and are accessible to the general public, with limited exceptions, under the Freedom of Information Act 2000, the Environment Regulations 2004, the

General Data Protection Regulation (GDPR) and the Data Protection Act 2018. Employees are required to be conversant and to comply with the Belfast Health and Social Care Trust policies on Information Governance including for example the ICT Security Policy, Data Protection Policy and Records Management Policy and to seek advice if in doubt.

For further information on how we use your personal data within HR, please refer to the Privacy Notice available on the HUB or Your HR

Environmental Cleaning Strategy

The Trusts Environmental Cleaning Strategy recognises the key principle that “Cleanliness matters is everyone’s responsibility, not just the cleaners” Whilst there are staff employed who are responsible for cleaning services, all Trust staff have a responsibility to ensure a clean, comfortable, safe environment for patients, clients, residents, visitors, staff and members of the general public.

Infection Prevention and Control

The Belfast Trust is committed to reducing Healthcare associated infections (HCAIs) and all staff have a part to play in making this happen. Staff must comply with all policies in relation to Infection Prevention and Control and with ongoing reduction strategies. Standard Infection Prevention and Control Precautions must be used at all times to ensure the safety of patients and staff.

This includes:-

Cleaning hands either with soap and water or a hand sanitiser at the appropriate times (WHO ‘5 moments’);
Using the correct ‘7 step’ hand hygiene technique;
Being ‘bare below the elbows’ when in a clinical environment;
Following Trust policies and the Regional Infection Control Manual (found on intranet);
Wearing the correct Personal Protective Equipment (PPE);
Ensuring correct handling and disposal of waste (including sharps) and laundry;
Ensuring all medical devices (equipment) are decontaminated appropriately i.e. cleaned, disinfected and/or sterilised;
Ensuring compliance with High Impact Interventions.

Personal Public Involvement

Staff members are expected to involve patients, clients, carers and the wider community were relevant, in developing, planning and delivering our services in a meaningful and effective way, as part of the Trust’s ongoing commitment to Personal Public Involvement (PPI).

Please use the link below to access the PPI standards leaflet for further information.

http://www.publichealth.hscni.net/sites/default/files/PPI_leaflet.pdf

Clause: This job description is not meant to be definitive and may be amended to meet the changing needs of the Belfast Health and Social Care Trust.

PERSONNEL SPECIFICATION

JOB TITLE / BAND: Lead Pharmacist Regional Pharmaceutical Quality
Assurance Service / Band 8D

DEPT / DIRECTORATE: Pharmacy Services / Cancer and Specialist Services
Directorate

Notes to applicants:
You must clearly demonstrate on your application form under each question, how you meet the required criteria as failure to do so may result in you not being shortlisted. You should clearly demonstrate this for both the essential and desirable criteria.
Shortlisting will be carried out on the basis of the essential criteria set out below, using the information provided by you on your application form. Please note the Trust reserves the right to use any desirable criteria outlined below at shortlisting. You must clearly demonstrate on your application form how you meet the desirable criteria.
Proof of qualifications and/or professional registration will be required if an offer of employment is made – if you are unable to provide this, the offer may be withdrawn.

ESSENTIAL CRITERIA

The following are ESSENTIAL criteria which will initially be measured at shortlisting stage although may also be further explored during the interview/selection stage.
You should therefore make it clear on your application form whether or not you meet these criteria. Failure to do so may result in you not being shortlisted. The stage in the process when the criteria will be measured is stated below.

Factor
Criteria
Method of Assessment

Qualifications
Registration
Experience
MPharm or equivalent.
Member of the Pharmaceutical Society of NI or eligible for membership.
Minimum of a post graduate Masters or higher qualification.
Minimum of three years’ hospital experience at band 8B or above (i) in an MHRA licensed manufacturing unit (production or quality control) and/ or (ii) in a pharmacy Section 10 aseptic dispensing unit.

Shortlisting by Application Form

Other (e.g. Driving etc.)

Have access to transport and be able to respond to a regional emergency gas testing call within the time limit set within the regionally agreed specification, under normal travelling conditions.

Have access to transport and be able to respond to a Plenum Building or VPKBN emergency alarm call within 45 minutes under normal travelling conditions and have access to transport in order to respond.

‘Where disability prohibits driving, this criteria will be waived if the applicant is able to organise suitable alternative arrangements.’

Shortlisting by Application Form

Knowledge
Skills
Abilities
Have successfully demonstrated high level strategic and people management, governance and organisational skills.
Have delivered against a challenging performance targets, making significant improvements.
A detailed understanding of good manufacturing practice and pharmaceutical quality systems medication safety.
An understanding of NHS or HSC risk and governance within pharmacy and the wider secondary healthcare environment.
Excellent planning, communication, organisational and influencing skills (written, oral, presentational and interpersonal) with the ability to communicate effectively with all levels of staff.

Shortlisting by Application Form
And
Interview

DESIRABLE CRITERIA

Desirable criteria will ONLY be used where it is necessary to introduce additional job related criteria to ensure files are manageable. You should therefore make it clear on your application form how you meet these. Failure to do so may result in you not being shortlisted.

Factor
Criteria
Method of Assessment

Qualifications
Registration
Experience

To be a Qualified Person (QP) includes transitional.
To have a diploma in Pharmaceutical Technology and Quality Assurance (PTQA).
To have experience within an MHRA licensed sterile manufacturing unit.

Shortlisting by Application Form

NOTE:
Where educational/professional qualifications form part of the criteria you will be required, if shortlisted for interview, to produce original certificates and one photocopy of same issued by the appropriate authority. Only those certificates relevant to the shortlisting criteria should be produced. If educational certificates are not available an original letter and photocopy of same detailing examination results from your school or college will be accepted as an alternative.

If successful you will be required to produce documentary evidence that you are legally entitled to live and work in the United Kingdom. This documentation can be a P45, Payslip, National Insurance Card or a Birth Certificate confirming birth in the United Kingdom or the Republic of Ireland. Failure to produce evidence will result in a non-appointment.

Where a post involves working in regulated activity with vulnerable groups, post holders will be required to register with the Independent Safeguarding Authority.

Healthcare Leadership Competencies

Candidates who are shortlisted for interview will need to demonstrate at interview that they have the required competencies to be effective in this demanding leadership role.

The competencies concerned are set out in the NHS Healthcare Leadership Model, details of which can be found at:

http://www.leadershipacademy.nhs.uk/resources/healthcare-leadership-model.

Particular attention will be given to the following:
Inspiring shared purpose
Leading with care
Evaluating information
Connecting our service
Sharing the vision
Engaging the team
Holding to account
Developing capability
Influencing for results

HSC Values

Whilst employees will be expected to portray all the values, particular attention is drawn to the following values for this role