Job summary
- Main area
- Pharmacy Quality Assurance
- Grade
- NHS AfC: Band 5
- Contract
- Permanent
- Hours
- Full time
- Flexible working
- Job ref
- 164-7402970
- 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
Employer heading
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
Essential criteria
- 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.
Desirable criteria
- Specialist courses in Quality Assurance or related specialty
Commitment to Trust Values and Behaviours
Essential criteria
- Must be able to demonstrate behaviours consistent with the Trust’s “Kind, Inclusive, Ambitious, One Team’’ behavioural standards
Experience
Essential criteria
- 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
Desirable criteria
- 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
Essential criteria
- 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.
Desirable criteria
- Excellent professional relationships built with other Pharmacy teams; including Production, Distribution, Radiopharmacy & Dispensary
Analytical and Judgement Skills
Essential criteria
- 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
Essential criteria
- Able to plan, prioritise and organise self, and manage own workload
- Working to instruction without supervision, Meeting deadlines whilst under pressure.
Physical Skills
Essential criteria
- Ability to work in varying environments (e.g. laboratory, clean rooms, stores areas)
Desirable criteria
- Ability to drive or otherwise travel between the locations of internal/external Trusts.
Other requirements specific to the role
Essential criteria
- 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
Employer certification / accreditation badges
.png "NHS Rainbow badge")
Applicant requirements
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
- Head of Quality (Interim)
- Email address
- [email protected]
- Telephone number
- 01159709431
List jobs with Nottingham University Hospitals NHS Trust in Health Science Services or all sectors