Job summary
- Main area
- Quality Control/Assurance
- Grade
- Band 8a
- Contract
- Secondment: 9 months
- Hours
- Full time
- Flexible working
- Job ref
- 164-7095131
- Employer
- Nottingham University Hospitals NHS Trust
- Employer type
- NHS
- Site
- Nottingham University Hospitals NHS Trust, QMC Campus
- Town
- Nottingham
- Salary
- £53,755 - £60,504 per annum
- Salary period
- Yearly
- Closing
- 10/04/2025 23:59
- Interview date
- 21/04/2025
Employer heading
Quality Assurance Manager – Technical Services
Band 8a
Job overview
The Pharmacy Quality Assurance (QA) team is responsible for driving quality within the whole of Pharmacy Technical Services, which includes the Sterile Production, Non-Sterile Production, and Prepacking Units, Pharmacy Stores, Quality Control and Quality Assurance functions based at QMC and Cytotoxic Chemotherapy Laboratory on the City Hospital Campus.
The post holder will support the Head of Quality with all aspects of QA to ensure that the service is fit for purpose. This will be achieved by taking a lead role in developing and implementing an effective(QMS); and managing the QA team.
The post holder will provide Quality Assurance leadership and support to all licensed and unlicensed production facilities, QC laboratory, and areas covered by the Wholesale Dealing Authorisation, in accordance with the strategic framework as defined by the Head of Quality. They will also develop and implement the QMS within the Radiopharmacy Department to enable integration of all sections of Technical Services.
The post holder will lead the QMS development, by providing leadership, support, expert advice and guidance. The post holder will be expected to deliver on a range of projects, and lead on the development of wider Quality Assurance issues.
The post holder will be expected to liaise with regulatory bodies such as the MHRA and Regional Quality Assurance Specialists, as well as NUH and non-NHU clients and senior members of the Pharmacy team and Clinical Support Division.
Main duties of the job
The post holder will provide Quality Assurance leadership and support to all licensed and unlicensed production facilities, QC laboratory, and areas covered by the Wholesale Dealing Authorisation, in accordance with the strategic framework as defined by the Head of Quality. They will also develop and implement the QMS within the Radiopharmacy Department to enable integration of all sections of Technical Services.
The post holder will lead the QMS development, by providing leadership, support, expert advice and guidance. The post holder will be expected to deliver on a range of projects, and lead on the development of wider Quality Assurance issues.
This will be done through development, planning, co-ordinating, delivering and evaluation of operational activity within Technical Services, ensuring excellent communication channels are built and ensuring work is completed within deadlines.
The post holder will be expected to liaise with regulatory bodies such as the MHRA and Regional Quality Assurance Specialists, as well as NUH and non-NHU clients and senior members of the Pharmacy team and Clinical Support Division.
Working for our organisation
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.
Detailed job description and main responsibilities
- To support the Head of Quality in developing and maintaining the QA services to a standard that can safely meet the Trust and patients’ needs and maintain the relevant MHRA licences held
- To develop, implement and manage the Quality Management System for Pharmacy Technical Services, to include but not limited to deviation management, change control, complaints and corrective and preventative actions.
- To develop and monitor quality indicators to critically assess the Quality Management System ensuring the principles of continuous quality improvement are maintained.
- To compile and collate information and lead the designated team responsible for investigations of quality exception reports.
- To track and establish trends in quality exception reports and ensure identified trends are escalated
- To develop and manage the Documentation Management System, ensuring that all required documentation is available and accurately reflects the actual practices undertaken. This will require the post holder, authors, reviewers and approvers to work together in a positive and collaborative manner to ensure documents are reviewed and approved in a timely manner.
- To respond to customer complaints and undertake drug defect investigations for NUH manufactured products
- To support senior Production and Quality Control staff in monitoring available capacity to ensure adequate staffing resource is available.
- Work closely with cross functional teams responsible for manufacturing, quality assurance, suppliers/service providers, Finance and clinical services to ensure correct reporting of data and resolve any queries utilising validated PQS systems and processes and provide expert guidance on manufacturing/quality related issues
- To develop and maintain the Validation Master Plan in conjunction with senior production and Quality Control staff. This should include validation of facilities, equipment, processes and computer systems.
- To monitor compliance and timely completion of validation activities to ensure the key objectives of the Validation Master Plan are met.
- To maintain Quality Assurance records, both paper and electronic, in compliance with current guidance, data integrity and legal responsibilities.
- To develop and maintain the internal audit programme
- To monitor compliance and timely completion of audit activities.
- To carry out regular internal audits as part of the team of designated auditors to ensure compliance with GMP and GDP.
- To participate in external inspections carried out by MHRA or SPS QA Specialists to ensure ongoing regulatory compliance.
- Provide a source of expertise and guidance on procedures for all Quality related disciplines in line with MHRA Guidelines, EUDRALEX Vol 4, PIC/S, Quality Assurance of Aseptic Preparation Services (QAAPS) and NHS Yellow cover documents.
- Keeping abreast of MHRA regulatory/ICH standards, requirements and GxP procedures/policies and undertaking the implementation of these policies. Interpret and lead on the local implementation of these policies across the Technical Services department and managing cultural change as required to embed new ways of working.
- To collate audit findings (internal and external) and lead on the development and implementation of action plans in response to identified deficiencies.
- To develop and support the implementation of appropriate Quality Assurance training programmes for pharmacy staff
- To maintain and develop links with relevant professional bodies and organisation e.g. General Pharmaceutical Council, Medicines and Healthcare products Regulatory Agency, Specialist Pharmacy Services.
- To act as a Releasing Officer where necessary for manufactured, repackaged and overlabelled products under the MHRA (Specials) Licence
Person specification
Training & Qualifications
Essential criteria
- Educated to a minimum of Degree level in Biology, Chemistry, Pharmacy or a related subject;
- Substantial post qualification relevant GMP experience and QA knowledge acquired through training to Masters degree or equivalent level of knowledge
Desirable criteria
- Eligible to be a member of one of the Professional bodies (Chemistry, Pharmacy, and Biology).
Commitment to Trust Values and Behaviours
Essential criteria
- Must be able to demonstrate behaviours consistent with the Trust’s behavioural standards
Experience
Essential criteria
- Experienced in leading highly complex projects, Extensive experience in the development of Pharmaceutical Quality System, processes and procedures including application of quality risk management principles. Experience of carrying out Quality Audits
- Broad understanding of MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors and ICH / PIC/S guidelines Experience and evidence of implementing effective service improvements
Desirable criteria
- Quality Control experience, including experience as a releasing officer.
- Experience in Pharmaceutical Quality Management Systems Pharmacy Production experience working under Section 10 of the Human Medicines Regulations or an MHRA licensed facility. Experience of investigating medication errors in a sensitive but thorough manner
Communication and Relationship skills
Essential criteria
- writing and policy development. Ability to provide and receive highly complex, sensitive and contentious information, negotiate with senior staff and external stakeholders on difficult and controversial issues, and present highly complex and sensitive information to large and influential groups. Strong interpersonal skills including the ability to persuade and influence others and deliver presentations in a variety of settings.
- Experience of Leading /Managing teams Ability to build successful teams Ability to influence and motivate staff to deliver challenging targets Ability to manage conflict
- Ability to influence and motivate staff to deliver challenging targets within complex projects Demonstrates negotiation skills Able to motivate and support others and encourage effective team working Able to communicate highly complex information which may be subject to challenge Able to communicate complex information in order to persuade others how to comply with National Guidance on QA matters
Desirable criteria
- Experience in carrying out appraisals of staff
Analytical and Judgement skills
Essential criteria
- Able to analyse data for trending purposes and to produce management reports Thorough and accurate work required for review of laboratory results which include highly complex data and batch documentation prior to release or rejection of the product including Judgement required for problem solving in environmental monitoring situations, particularly when non-compliance is an issue Able to assess complex drug stability data to support shelf life assignment Required to use own initiative and professional judgment and can demonstrate ability to overcome challenges and initiate change.
- Highly developed problem solving skills
Desirable criteria
- Able to utilise knowledge of GMP, and Regulatory guidelines to be able to advise clients and Pharmacy managers on all aspects of Quality Assurance
Planning and organisation skills
Essential criteria
- Able to develop and manage a Quality Management System Able to plan the workload to meet deadlines. Able to monitor and organise the progress against action plans, for self-inspection and external audit to ensure continued GMP Compliance. Must be able to alter workflow to meet changing Department and Pharmacy needs. Able to arrange and chair meetings with senior Technical Services staff. Able to concentrate for long periods of time to review complex data. Experience of setting up and implementing internal processes and procedures.
Desirable criteria
- Able to develop and manage an electronic Quality Management System. Experience of carrying out audits to GMP
Physical skills
Essential criteria
- Demonstrates a high level of attention to detail. Able to work in enclosed spaces in Clean Room environments
Other requirements specific to the role (e.g. be able to work shifts/on call)
Essential criteria
- Candidate should be able to drive to other sites to conduct/participate in audits. Candidate will also be expected to be on call for medical gases, driving to do external medical gas testing may be required.
Employer certification / accreditation badges
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Applicant requirements
You must have appropriate UK professional registration.
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Documents to download
Further details / informal visits contact
- Name
- Zeeshan Janjua
- Job title
- Quality Manager
- Email address
- [email protected]
- Telephone number
- 0115 9249924
- Additional information
0115 9249924 ext: 87750
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