Employer Nottingham University Hospitals NHS Trust Employer type NHS Site Queen's Medical Centre Town Nottingham Salary £31,049 - £37,796 per annum Salary period Yearly Closing 06/10/2025 23:59
Quality Assurance Officer
NHS AfC: Band 5
Job overview
The Quality Assurance Officer assists the Quality Assurance Manager and QA Releasing Officers in providing a Quality Assurance service to a number of internal/external NHS and commercial clients.
· The post holder is responsible for maintaining the day-to-day Quality Management Systems (QMS) within NUH QMC and City Hospital working closely with QA manager and QA releasing officers.
· The post holder will work closely with the Stores manager, Responsible Person, Production manager and Quality manager to ensure action points from internal and external audits in Stores and Production are achieved within the given timeframes.
· The post holder will participate in the completion of audit actions from external and internal inspections for Stores and Production department.
· The QMS covers change control management, investigation of quality issues, handling and investigating customer complaints, internal and external audits, deviation management, batch rejections, documentation control (review/approval/issue).
· The post holder will take an active role in the maintenance of computer and paper-based systems and procedures to ensure the QMS meets the regulatory requirements of MHRA and supports the continuous improvement processes.
· The post holder will liaise with all levels of staff within QMC and City to ensure the QMS and QA requirements are met.
Main duties of the job
The post holder is required to participate in the day-to-day management of the Quality Management System and the rigorous compliance with GMP in QMC and City Standard Operating Procedures.
To assist in the maintenance and development of the Quality Management Systems across Pharmacy Quality, Production and Stores, including but not limited to writing, reviewing and updating department procedures and policies and maintaining and developing the department’s change control, deviation, complaints, recall and corrective action and preventative action (CAPA) systems.
See attached job description and person specification for further details.
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
Good Distribution Practice/Quality/Regulatory
1. Participates in the day-to-day management of the Quality Management System and the rigorous compliance with GMP in QMC and City Standard Operating Procedures.
2. Takes an active role in supporting the Quality Assurance manager in the upkeep of a central computer QMS database for the unit organisation.
3. Supports the Quality Assurance team in the upkeep of a central computer Documentation database for the unit organisation.
4. Facilitates investigations into Quality events and non-conformances, ensuring root cause analysis is undertaken and preventative measures are identified in order to prevent re-occurrence
5. Provides guidance on the assignment of appropriate corrective and preventative actions to all levels of staff within NUH.
6. Participates in the evaluation of complex change requests from NUH and assigns actions to ensure that changes do not impact on the safety, quality or efficacy of QMC products
7. Supports senior QA team during self- inspection audits and agreement of corrective action plans with the relevant section head.
8. Provides support and guidance in the review system to ensure all QMS reports are reviewed for successful implementation of corrective and preventative actions.
9. Prepares and carries out validation protocols closely with the QC team.
10. In collaboration with the QA Manager and other senior staff ensure all activities in the department are carried out in accordance with the principles of GMP, ensuring that all medicines manufactured are of the required quality, safety and efficiency.
11. Take minutes at Quality and Distribution meetings.
12. Participate in document control including copying, issuing, scanning, distributing documents both internally and with external parties.
13. Support Production and Stores in the management and completion of CAPAs.
14. Perform effectiveness review of changes, deviations, complaints, risk assessments and escalate any concerns to the QA manager, responsible person or the Production manager.
15. Participate in the release of raw materials/Unlicensed Medicines.
16. Provide support to releasing officers in conducting audits and the implementation of actions required to address deficiencies in various departments: Production, Stores, Quality assurance, Quality Control and Radiopharmacy.
17. Support QA/QC in the calibration of data loggers, temperature mapping of fridges, rooms and incubators.
18. Carry out routine temperature mapping of temperature controlled equipment and areas within Pharmacy Stores. Prepare mapping reports and investigate any issues (if required).
Resources Planning
19. Ensure all preventative measures are assigned with achievable timeframes.
20. Ensures that all change requests are assessed and processed in a timely manner.
21. Support where needed to NSM (Non-Sterile Manufacturing) with product release activity to ensure release of tablet packed products meet the required manager times.
22. Ensures that accurate computerised records are maintained to facilitate senior management decision making.
23. Contributes in identifying action plans to achieve cost savings within QC/QA/Stores.
Staff Management and Training
24. Helps to maintains staff awareness of QMS systems and ensures the system is efficient.
25. Participates in the training of staff in Quality Assurance and QMS.
26. Participates in presenting on a monthly basis to all section heads and senior management on the progress of the QMS using Microsoft software.
Documentation
27. Reviews Standard Operating Procedures within QA / Pharmacy Stores and the wider QMC AND CITY hospital sites, in accordance with the procedures.
28. Regularly reviews the training manual within the QA / Pharmacy Stores department
29. Assists in the maintenance of the quality document management system ensuring production, approval, issue and review of documents is performed in a compliant manner
Other Duties
30. Identifies and participates in training and development opportunities to support Continuing Professional Development.
31. Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation.
Person specification
Training & Qualifications
* BSc in Chemistry, Pharmaceutical Science or equivalent Science Degree, Qualified Pharmacy Technician or equivalent level of knowledge.
* Excellent IT skills, Competent use of Microsoft office applications
* Demonstrates commitment to CPD in order to maintain QMS and QA knowledge and skills.
* Specialist courses in Quality Assurance or related specialty
Commitment to Trust Values and Behaviours
* Must be able to demonstrate behaviours consistent with the Trust’s “Kind, Inclusive, Ambitious, One Team’’ behavioural standards
Experience
* Specialist knowledge of Good Manufacturing Practice, Quality assurance and quality management gained through practical experience or post qualification training.
* Experience of managing deviations/incidents/CAPAs/change controls
* Experience of investigative report writing and presentation of data to senior leadership team
* Experience in WDA licensed activities within NHS Pharmacy stores or commercial pharmacy setting
* Substantial post qualification Good Manufacturing Practice and Good Distribution Practice experience
* Basic understanding of Pharmaceutical microbiology and its impact on product quality and patient safety.
Communication and Relationship Skills
* Communicate specialist/complex information to an audience of specialist and non-specialist stakeholders.
* Demonstrated ability to influence senior staff, multidisciplinary teams and management
* Demonstrated effective customer service sills, Good team worker, Effective remote communication with off-site units and agencies.
* Manage own workload, Attention to detail, Excellent verbal and communication skills.
* Excellent professional relationships built with other Pharmacy teams; including Production, Distribution, Radiopharmacy & Dispensary
Analytical and Judgement Skills
* Ability to plan and prioritise work requirements and demands
* Demonstrate ability to identify problems, analyse root cause and propose solution for complex problems, Ability to use initiative in problem solving.
Planning and Organisation Skills
* Able to plan, prioritise and organise self, and manage own workload
* Working to instruction without supervision, Meeting deadlines whilst under pressure.
Physical Skills
* Ability to work in varying environments (e.g. laboratory, clean rooms, stores areas)
* Ability to drive or otherwise travel between the locations of internal/external Trusts.
Other requirements specific to the role
* Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services, Able to develop new systems of work
* Ability to work to deadlines and meet objectives and targets
___________________________________________________________________________________
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.
NUH are now able to offer application completion support and interview preparation support. Please follow the link to book onto our sessions: Support for NUH Job Applications
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
Salary: The quoted salary will be on a pro rata basis for part time workers.
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.
ID and Right to work checks: NUH authenticate ID and right to work documentation including passports and driving licenses through a system called Trust ID. NUH will scan your ID and right to work documentation in to the Trust ID system at your face to face ID appointment. 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.
Employer certification / accreditation badges
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.
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