Quality Assurance Manager – Technical Services

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.

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

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.

1. 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
2. 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.
3. To develop and monitor quality indicators to critically assess the Quality Management System ensuring the principles of continuous quality improvement are maintained.
4. To compile and collate information and lead the designated team responsible for investigations of quality exception reports.
5. To track and establish trends in quality exception reports and ensure identified trends are escalated
6. 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.
7. To respond to customer complaints and undertake drug defect investigations for NUH manufactured products
8. To support senior Production and Quality Control staff in monitoring available capacity to ensure adequate staffing resource is available.
9. 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
10. 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.
11. To monitor compliance and timely completion of validation activities to ensure the key objectives of the Validation Master Plan are met.
12. To maintain Quality Assurance records, both paper and electronic, in compliance with current guidance, data integrity and legal responsibilities.
13. To develop and maintain the internal audit programme
14. To monitor compliance and timely completion of audit activities.
15. To carry out regular internal audits as part of the team of designated auditors to ensure compliance with GMP and GDP.
16. To participate in external inspections carried out by MHRA or SPS QA Specialists to ensure ongoing regulatory compliance.
17. 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.
18. 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.
19. To collate audit findings (internal and external) and lead on the development and implementation of action plans in response to identified deficiencies.
20. To develop and support the implementation of appropriate Quality Assurance training programmes for pharmacy staff
21. 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.
22. To act as a Releasing Officer where necessary for manufactured, repackaged and overlabelled products under the MHRA (Specials) Licence

Person specification

Training & Qualifications

• 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

• Eligible to be a member of one of the Professional bodies (Chemistry, Pharmacy, and Biology).

Commitment to Trust Values and Behaviours

• Must be able to demonstrate behaviours consistent with the Trust’s behavioural standards

Experience

• 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

• 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

• 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

• Experience in carrying out appraisals of staff

Analytical and Judgement skills

• 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

• 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

• 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.

• Able to develop and manage an electronic Quality Management System. Experience of carrying out audits to GMP

Physical skills

• 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)

• 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.

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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 the 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.

Applicants are kindly requested to refrain from using AI at any stage during the recruitment process.

Closing Dates: Please submit your application form as soon as possible to avoid disappointment; we reserve the right to close vacancies prior to the published closing date if we receive a sufficient number of completed application forms.

Communication: All communication related to your application will be via the email address you have provided. Please ensure you check your email account including your junk email regularly.

Easy read application: if you have a disability and find it difficult to complete our online application form, you can apply via our easy read application which you can find on the intranet https://www.nuh.nhs.uk/easy-read-job-application

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If you are aged 16 or 17 and applying for a role that is more than 20 hours a week, please be aware that you will be asked to commence an Apprenticeship within the Trust alongside your role, as long as there is a suitable apprenticeship standard available. This is in line with the current guidance in England that whilst young people under the age of 18 can leave school (on the last Friday in June) they must then do one of the following:

• Stay in full-time education, for example at a college
• Start an Apprenticeship
• Spend 20 hours of more a week working or volunteering, while in part-time education or training

For more details visit; School leaving age - GOV.UK (www.gov.uk)

Disability Confidence: All applicants who have declared a disability and who meet the essential criteria for the post will be shortlisted.

At Risk of redundancy: NHS employees within the East Midlands who are ‘at risk’ of redundancy will be given a preferential interview where they meet the essential criteria of the person specification.

International Recruitment: If you are applying for a role with us from outside of the UK then please read the guidance on applying for a health or social care job in the UK from abroad.

The system will run a check against the key security features within your documentation. The system will provide us with an outcome of your check which will be stored securely on your personal file along with all other pre-employment check documentation.

Consent:

• Transfer of information: If I have previous NHS service - I consent to the transfer of my Electronic Staff Record (ESR) data between this and other NHS Trusts. I also consent to the Occupational Health Department confidentially accessing my occupational health records from my current or previous employer in order to check the status of my vaccinations, immunisations s and screening tests as relevant to the post. I understand this is an automated process and the information will only be used for these purposes prior to me taking up the position at NUH.
• Disclosure and Barring Service: Your post maybe subject to a DBS check which incur a cost dependent on the level of check required (£49.50 for enhanced and £21.50 for standard). I agree to reimburse Nottingham University Hospitals NHS Trust the cost of a Disclosure and Barring Service (DBS) check if it is required (by deduction from first month’s pay). Should I decide to withdraw from my job offer, I agree to reimburse Nottingham University Hospitals NHS Trust the cost of the DBS check undertaken by cheque or other agreed method.
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