Job summary
Participates in audits including Government lead Inspections of services and facilities by the Medicines and Healthcare Products Regulatory Agency (MHRA) in relation to the Departments Wholesaler Dealers Authorisation (WDA <H>) ensuring continued maintenance of current licenses within Pharmacy.
Responsible for the delivery of regulatory action plans post inspection relating to wholesale dealing practices.
Ability to provide support (for annual leave and sickness) for the day-to-day management of staff and workload of the Pharmacy Procurement team.
Responsible for ensuring effective reports are presented at QMS and governance meetings
Main duties of the job
Working effectively as a team member in the provision of MHRA Regulatory compliance within the Pharmacy Department.
To support development and delivery of a comprehensive wholesale dealing Service to end users, as well as providing Procurement support to the Pharmacy Procurement team.
To lead the WDA <H> (wholesale Dealers Authorisation for Human use) audit programme across the Pharmacy Department, including external audits of 3rd party suppliers of services to the organisation when required. To present findings in accordance with MHRA legislation to department Responsible Person (RP) and deputies at regular service review meetings and QMS.
To be responsible for maintaining a robust integrated WDA system across the Pharmacy Department.
To manage the day-to-day WDA processes to support the department RPs to enable the safe and effective management of wholesale dealing practices under MHRA legislation.
To provide day-to-day MHRA Regulatory support on WDA matters to other departments in NBT and to external customers of the WDA(H) license.
To undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
About us
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services. North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
If you are from outside the area, Bristol is consistently voted as one of the best places to live in the UK, with a rich history, thriving arts, music, gastronomic and independent retails scenes, excellent transport links and easy access to the spectacular countryside and coastlines of South Wales, Devon, and Cornwall.
Job description
Job responsibilities
Working effectively as a team member in the provision of MHRA Regulatory compliance within the Pharmacy Department.
To support development and delivery of a comprehensive wholesale dealing Service to end users, as well as providing Procurement support to the Pharmacy Procurement team.
To lead the WDA <H> (wholesale Dealers Authorisation for Human use) audit programme across the Pharmacy Department, including external audits of 3rd party suppliers of services to the organisation when required. To present findings in accordance with MHRA legislation to department Responsible Person (RP) and deputies at regular service review meetings and QMS.
To be responsible for maintaining a robust integrated WDA system across the Pharmacy Department.
To manage the day-to-day WDA processes to support the department RPs to enable the safe and effective management of wholesale dealing practices under MHRA legislation.
To provide day-to-day MHRA Regulatory support on WDA matters to other departments in NBT and to external customers of the WDA(H) license.
To undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
Participates in audits including Government lead Inspections of services and facilities by the Medicines and Healthcare Products Regulatory Agency (MHRA) in relation to the Departments Wholesaler Dealers Authorisation (WDA <H>) ensuring continued maintenance of current licenses within Pharmacy.
Responsible for the delivery of regulatory action plans post inspection relating to wholesale dealing practices.
Ability to provide support (for annual leave and sickness) for the day-to-day management of staff and workload of the Pharmacy Procurement team.
Job description
Job responsibilities
Working effectively as a team member in the provision of MHRA Regulatory compliance within the Pharmacy Department.
To support development and delivery of a comprehensive wholesale dealing Service to end users, as well as providing Procurement support to the Pharmacy Procurement team.
To lead the WDA <H> (wholesale Dealers Authorisation for Human use) audit programme across the Pharmacy Department, including external audits of 3rd party suppliers of services to the organisation when required. To present findings in accordance with MHRA legislation to department Responsible Person (RP) and deputies at regular service review meetings and QMS.
To be responsible for maintaining a robust integrated WDA system across the Pharmacy Department.
To manage the day-to-day WDA processes to support the department RPs to enable the safe and effective management of wholesale dealing practices under MHRA legislation.
To provide day-to-day MHRA Regulatory support on WDA matters to other departments in NBT and to external customers of the WDA(H) license.
To undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
Participates in audits including Government lead Inspections of services and facilities by the Medicines and Healthcare Products Regulatory Agency (MHRA) in relation to the Departments Wholesaler Dealers Authorisation (WDA <H>) ensuring continued maintenance of current licenses within Pharmacy.
Responsible for the delivery of regulatory action plans post inspection relating to wholesale dealing practices.
Ability to provide support (for annual leave and sickness) for the day-to-day management of staff and workload of the Pharmacy Procurement team.
Person Specification
Education/Training/Qualifications
Essential
- NVQ Level 3 or equivalent, or BTEC National Certificate in Pharmacy Services, or a recognised equivalent qualification
- Current registration with the General Pharmaceutical Council as a practising hospital pharmacy technician
- Recognised current Accredited Checking Technician qualification
- IT competencies equivalent to ELITE/ECDL, including experience of using specific Pharmacy I.T stock control and ordering systems such as Ascribe/EMIS,JAC, HP etc., including a good working knowledge of standard PC software such as Microsoft Office packages
- Evidence of continuing CPD
Desirable
- MHRA GDP trained
- Leadership and Management level 3
- Chartered Institute of Procurement Specialists (CIPS) Qualification
Work Experience
Essential
- Experience of managing a team (3 or more members in a Team) and multidisciplinary working Current/recent management of an Acute UK Hospital Pharmacy and up to date knowledge of Regulatory Compliance in relation to MHRA wda authorisations Minimum 2 years post qualified experience working as a pharmacy Technician in an Acute UK Hospital, of which a minimum of 1 years' experience of a supervisory/management role at Band 5, or above Experience of project management and service improvement Experience with implementation of corrective action programs and strong IT skills including Microsoft Office Experience of writing and developing Standard Operating Procedures Experience of internal and external audit Knowledge and understanding of Wholesale Distribution Authorisation (WDA) for Medicinal Products Knowledge of Quality Management Systems and QA applications, such a Q-PULSE. Knowledge in and implementation of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) Medicines and Healthcare Products Regulatory Agency (MHRA) and licensing guidelines and standards
Desirable
- Experience of equipment and method validation
- Experience of change operational management and root cause analysis
Knowledge/Skills/Abilities
Essential
- Ability to react to, and manage changing situations required by the organisation on a daily basis liaise with staff accordingly - to know when to escalate.
- Excellent time management skills
- Excellent communication, interpersonal and organisational skills
- Standard I.T. competencies in Word, PowerPoint and Excel or equivalent programs
- Ability to plan personal and departmental workload on both short (days) and long term (months)
- Ability to develop service (including procedures)
- Ability to be flexible and maintain objectivity when under pressure
- Ability to manage 'change control' processes and implement / monitor "Corrective And Preventive Actions" (CAPA)
- Knowledge of current procurement practices and legislation
Desirable
- Experience (with evidence) of managing major operational change within an organisation
- Training skills
Personal Qualities/Special Circumstances
Essential
- Self-motivated individual with an organised and logical approach to Work - able to motivate team
- Able to deal and communicate professionally with all levels of staff within own organisation, other NHS organisations, Industry and Pharma partners as well as patients
- Staff are required to work any combination of hours between 08:00am - 18:00pm. Shift patterns will be allocated once appointed, as the Department is moving towards a full 7 day service, and will include weekend working on a rotational basis
- Able to concentrate on complex tasks for long periods
- Able to use initiative
- Able to concentrate on complex tasks for long periods
Person Specification
Education/Training/Qualifications
Essential
- NVQ Level 3 or equivalent, or BTEC National Certificate in Pharmacy Services, or a recognised equivalent qualification
- Current registration with the General Pharmaceutical Council as a practising hospital pharmacy technician
- Recognised current Accredited Checking Technician qualification
- IT competencies equivalent to ELITE/ECDL, including experience of using specific Pharmacy I.T stock control and ordering systems such as Ascribe/EMIS,JAC, HP etc., including a good working knowledge of standard PC software such as Microsoft Office packages
- Evidence of continuing CPD
Desirable
- MHRA GDP trained
- Leadership and Management level 3
- Chartered Institute of Procurement Specialists (CIPS) Qualification
Work Experience
Essential
- Experience of managing a team (3 or more members in a Team) and multidisciplinary working Current/recent management of an Acute UK Hospital Pharmacy and up to date knowledge of Regulatory Compliance in relation to MHRA wda authorisations Minimum 2 years post qualified experience working as a pharmacy Technician in an Acute UK Hospital, of which a minimum of 1 years' experience of a supervisory/management role at Band 5, or above Experience of project management and service improvement Experience with implementation of corrective action programs and strong IT skills including Microsoft Office Experience of writing and developing Standard Operating Procedures Experience of internal and external audit Knowledge and understanding of Wholesale Distribution Authorisation (WDA) for Medicinal Products Knowledge of Quality Management Systems and QA applications, such a Q-PULSE. Knowledge in and implementation of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) Medicines and Healthcare Products Regulatory Agency (MHRA) and licensing guidelines and standards
Desirable
- Experience of equipment and method validation
- Experience of change operational management and root cause analysis
Knowledge/Skills/Abilities
Essential
- Ability to react to, and manage changing situations required by the organisation on a daily basis liaise with staff accordingly - to know when to escalate.
- Excellent time management skills
- Excellent communication, interpersonal and organisational skills
- Standard I.T. competencies in Word, PowerPoint and Excel or equivalent programs
- Ability to plan personal and departmental workload on both short (days) and long term (months)
- Ability to develop service (including procedures)
- Ability to be flexible and maintain objectivity when under pressure
- Ability to manage 'change control' processes and implement / monitor "Corrective And Preventive Actions" (CAPA)
- Knowledge of current procurement practices and legislation
Desirable
- Experience (with evidence) of managing major operational change within an organisation
- Training skills
Personal Qualities/Special Circumstances
Essential
- Self-motivated individual with an organised and logical approach to Work - able to motivate team
- Able to deal and communicate professionally with all levels of staff within own organisation, other NHS organisations, Industry and Pharma partners as well as patients
- Staff are required to work any combination of hours between 08:00am - 18:00pm. Shift patterns will be allocated once appointed, as the Department is moving towards a full 7 day service, and will include weekend working on a rotational basis
- Able to concentrate on complex tasks for long periods
- Able to use initiative
- Able to concentrate on complex tasks for long periods
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.
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).
Additional information
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.
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).
