Job summary
Aseptics Quality Assurance Lead
Department: Pharmacy
Band 7 £43,742- £50,056 Per annum
Hours: 37.5 per week, all MKUH roles will be considered for flexible working
This is an exciting opportunity for a Pharmacist or Technician with experience of working in a pharmacy aseptic unit to join our growing but knowledgeable team as we develop and expand our aseptic services.
You will play a key role in developing and maintaining quality assurance within the aseptic team, building on existing systems while also assisting with the implementation of the Ideagen Quality Management System that is planned for the Pharmacy department in the near future.
We are at the early stages of planning for a significant expansion of our aseptic services as part of the East of England Aseptics Review process, and there may be opportunities for this post to grow alongside our developing services.
Our friendly team look forward to working with someone who has a passion for technical services, and who has experience of working in licensed or unlicensed aseptic units and is willing to share that knowledge for the benefit of the service.
Interview date: 8th July 2024
Main duties of the job
To ensure that all current Good Manufacturing Practice (GMP) Quality Assurance activities are effectively managed to meet agreed Trust and Pharmacy Department objectives whilst complying will all relevant national and local legislation, regulations and guidelines in relation to GMP.
Responsible for leading the implementing and maintaining of a Pharmaceutical Quality Management (PQS) System across all relevant areas of Pharmacy and monitor its effectiveness.
To provide expert quality assurance to the Pharmacy Aseptic Services Unit (PASU) in the quality review of their products and processes to maintain a high quality pharmaceutical aseptic service.
To ensure the delivery of a safe and efficient Aseptic Services Unit which meets all legal and professional standards.
To facilitate and support the efficient and cost effective use of medicines across Cancer and Aseptic Services.
To contribute to enhancing patient safety and ensuring a positive patient experience for all patients across Cancer and Aseptics.
About us
Our staff are the happiest NHS staff; MKUH staff scored highest for 'I look forward to coming to work' (NHS Staff Survey 2023).
You can expect a warm welcome at Milton Keynes University Hospital, our staff are friendly and welcoming. We listen to each other and work together to embed our Trusts values and behaviours. At MKUH we appreciate our staff and reward them with an outstanding benefits package including:
- Free on-site parking
- Free tea and coffee
- Great flexible workingopportunities
- Discounted gym membership
- Lease car scheme
- Generous annual leave and pension scheme
- On site nursery (chargeable)
- Extensive staff health and well-being programme
Milton Keynes University Hospital NHS Foundation Trust, in partnership with the University of Buckingham, is a University Teaching Hospital; we conduct research and teaching on site to improve the care of our patients. The hospital is undergoing significant investment, and we are proud to be rated good by the CQC. Visit our website to catch up on our latest news.
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
Responsible for implementing the Pharmacys department PQS, critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
To keep abreast of all standards and guidelines relevant to the work of the Pharmacy department. To interpret the standards and guidelines and ensure that all protocols and SOPs meet with current requirements.
Quality Exceptions
To assist in the regular quality assurance review of all internal and external quality exceptions. This will involve investigation of product and process errors, defects, non-compliance and service user complaints.
Work in co-operation with Aseptic Services Manager and Accountable Pharmacist to plan and implement corrective and preventative actions this may involve processes, procedure, training, policy, or service changes.
Pharmacy Aseptic Services Unit
To provide expert quality assurance advice to the Pharmacy Aseptic Services Unit (ASU) senior staff by undertaking quality review of products and production processes to actively seek, identify and promote best practice and maintain a high quality pharmaceutical aseptic service.
To liaise with the aseptic services senior staff to ensure adherence to current legislation and standards.
Please refer to Job Description for further details
MKUH is committed to equal opportunities and improving the working lives of our staff and as such we offer a range of flexible working practices. We promote an inclusive workforce and encourage applications from applicants from all backgrounds.
We reserve the right to expire vacancies prior to the advertised closing date once a sufficient number of applications have been received.
MKUH uses identification scanning technology to confirm the authenticity of documents; all prospective employees of MKUH will have their original documents verified using this technology.
By applying for this role, you accept if successful, that information from your application will be transferred into the national NHS Electronic Staff Record (ESR) system. Your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which aims at saving you time and improving efficiencies within the NHS when your employment transfers.
Upon commencing employment with the Trust, all employees (except Medical & Dental Staff on national terms and conditions) are subject to a probationary period lasting a period of six months with an option to extend for a further six months to a total of 12 months.
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
Responsible for implementing the Pharmacys department PQS, critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
To keep abreast of all standards and guidelines relevant to the work of the Pharmacy department. To interpret the standards and guidelines and ensure that all protocols and SOPs meet with current requirements.
Quality Exceptions
To assist in the regular quality assurance review of all internal and external quality exceptions. This will involve investigation of product and process errors, defects, non-compliance and service user complaints.
Work in co-operation with Aseptic Services Manager and Accountable Pharmacist to plan and implement corrective and preventative actions this may involve processes, procedure, training, policy, or service changes.
Pharmacy Aseptic Services Unit
To provide expert quality assurance advice to the Pharmacy Aseptic Services Unit (ASU) senior staff by undertaking quality review of products and production processes to actively seek, identify and promote best practice and maintain a high quality pharmaceutical aseptic service.
To liaise with the aseptic services senior staff to ensure adherence to current legislation and standards.
Please refer to Job Description for further details
MKUH is committed to equal opportunities and improving the working lives of our staff and as such we offer a range of flexible working practices. We promote an inclusive workforce and encourage applications from applicants from all backgrounds.
We reserve the right to expire vacancies prior to the advertised closing date once a sufficient number of applications have been received.
MKUH uses identification scanning technology to confirm the authenticity of documents; all prospective employees of MKUH will have their original documents verified using this technology.
By applying for this role, you accept if successful, that information from your application will be transferred into the national NHS Electronic Staff Record (ESR) system. Your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which aims at saving you time and improving efficiencies within the NHS when your employment transfers.
Upon commencing employment with the Trust, all employees (except Medical & Dental Staff on national terms and conditions) are subject to a probationary period lasting a period of six months with an option to extend for a further six months to a total of 12 months.
Person Specification
Qualifications and knowledge
Essential
- Relevant Science Degree
- Master's degree in pharmacy or NVQ Level 3 in Pharmacy Services and BTEC in Pharmaceutical Science or Equivalent qualification with substantial experience in the QA/QC field.
- Registered or eligible to register with an appropriate professional body.
Desirable
- Specialist higher diploma in technical services (e.g. PTQA or Scientific Training Programme) or working towards.
Experience
Essential
- Experience of pharmacy manufacturing or other significant experience of working in a GxP environment
- Quality control and quality assurance experience including environmental monitoring.
- Experience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and Corrective and Preventive actions.
- Experience of validation, qualification and recommissioning.
- Experience of conducting quality-based investigations and root cause analysis
- Experience in data interpretations and report writing.
- Experience of critically reviewing processes, recommending, and implementing changes as appropriate.
Desirable
- Experience of participation in external audit and hosting external auditors.
- Experience of line managing personnel
- Experience of conducting internal GxP quality assurance audits Experience of project management of complex systems
Skills
Essential
- Good organisational and time management skills.
- Able to work independently and show initiative within limits of own authority whilst following agreed procedures.
- Ability to work under pressure, prioritising work as appropriate to achieve deadlines Strong leadership and team working skills.
- Procedure and policy development
- Able to give feedback constructively and deal with issues sensitively.
- Skill of managing personnel within teams
- In depth and practical knowledge of the legislation and standards relating to GxP, ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System.
- Knowledge of clean room design and function and HTMs/HBNs
- Demonstrated knowledge of principles and practices of aseptic preparation
- Knowledge of pharmaceutical microbiology
- Demonstrable ability to identify problems, analyse complex root causes and propose practical and workable solutions for complex problems.
- Analytical and judgmental skills required to assess complex data and situations.
- Demonstrable ability to identify risk, carry out risk assessments, and manage action plans
- Knowledge and application of data integrity to GxP environments.
Desirable
- An understanding of analytical chemistry/methods /instruments.
- Good understanding of the procedures, protocols and legal requirements governing the issue of unlicensed medicines.
- Knowledge of CMM computer system
Personal and people development
Essential
- Proactive attitude to ongoing training, development and assessment.
- Responsible, flexible & professional in behaviour.
- Courteous in manner.
Communication
Essential
- Able to communicate in a clear and concise manner to a level where drug names can be accurately received, recorded, and given, as part of the role.
- Ability to write/notate in a clearly legible style.
- Able to attend internal and external meetings, off site training days, required overtime related to managing service delivery etc
- Willing to work in other areas of the Trust or Trust-wide as and when required to do so.
Specific requirements
Essential
- Able to perform the duties of the post with reasonable aids and adaptations. Self-motivated and driven to progress service provision, with ability to motivate team.
- Ability to work in an isolator fully gloved and gowned.
- Regular VDU usage.
- Ability to travel to external customers and suppliers when required.
Person Specification
Qualifications and knowledge
Essential
- Relevant Science Degree
- Master's degree in pharmacy or NVQ Level 3 in Pharmacy Services and BTEC in Pharmaceutical Science or Equivalent qualification with substantial experience in the QA/QC field.
- Registered or eligible to register with an appropriate professional body.
Desirable
- Specialist higher diploma in technical services (e.g. PTQA or Scientific Training Programme) or working towards.
Experience
Essential
- Experience of pharmacy manufacturing or other significant experience of working in a GxP environment
- Quality control and quality assurance experience including environmental monitoring.
- Experience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and Corrective and Preventive actions.
- Experience of validation, qualification and recommissioning.
- Experience of conducting quality-based investigations and root cause analysis
- Experience in data interpretations and report writing.
- Experience of critically reviewing processes, recommending, and implementing changes as appropriate.
Desirable
- Experience of participation in external audit and hosting external auditors.
- Experience of line managing personnel
- Experience of conducting internal GxP quality assurance audits Experience of project management of complex systems
Skills
Essential
- Good organisational and time management skills.
- Able to work independently and show initiative within limits of own authority whilst following agreed procedures.
- Ability to work under pressure, prioritising work as appropriate to achieve deadlines Strong leadership and team working skills.
- Procedure and policy development
- Able to give feedback constructively and deal with issues sensitively.
- Skill of managing personnel within teams
- In depth and practical knowledge of the legislation and standards relating to GxP, ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System.
- Knowledge of clean room design and function and HTMs/HBNs
- Demonstrated knowledge of principles and practices of aseptic preparation
- Knowledge of pharmaceutical microbiology
- Demonstrable ability to identify problems, analyse complex root causes and propose practical and workable solutions for complex problems.
- Analytical and judgmental skills required to assess complex data and situations.
- Demonstrable ability to identify risk, carry out risk assessments, and manage action plans
- Knowledge and application of data integrity to GxP environments.
Desirable
- An understanding of analytical chemistry/methods /instruments.
- Good understanding of the procedures, protocols and legal requirements governing the issue of unlicensed medicines.
- Knowledge of CMM computer system
Personal and people development
Essential
- Proactive attitude to ongoing training, development and assessment.
- Responsible, flexible & professional in behaviour.
- Courteous in manner.
Communication
Essential
- Able to communicate in a clear and concise manner to a level where drug names can be accurately received, recorded, and given, as part of the role.
- Ability to write/notate in a clearly legible style.
- Able to attend internal and external meetings, off site training days, required overtime related to managing service delivery etc
- Willing to work in other areas of the Trust or Trust-wide as and when required to do so.
Specific requirements
Essential
- Able to perform the duties of the post with reasonable aids and adaptations. Self-motivated and driven to progress service provision, with ability to motivate team.
- Ability to work in an isolator fully gloved and gowned.
- Regular VDU usage.
- Ability to travel to external customers and suppliers when required.
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.
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
