Quality Assurance Officer

NHS; Nottingham; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading healthcare provider in Nottingham is seeking a Quality Assurance Officer to assist in managing the Quality Management System and ensuring compliance with Good Manufacturing Practices. The ideal candidate will have a BSc in Chemistry or Pharmaceutical Science and experience in quality assurance. This role involves supporting investigations, reviewing documentation, and training staff in quality systems.

Benefits

Training and development opportunities

Job security within the NHS

Contribution to public health

Qualifications

• BSc in Chemistry, Pharmaceutical Science or equivalent Science Degree required.
• Excellent IT skills with competency in Microsoft applications.
• Experience in managing deviations/incidents/CAPAs/change controls.

Responsibilities

• Manage the Quality Management System and maintain compliance.
• Support investigations into Quality events and non-conformances.
• Assist in the review of Standard Operating Procedures.

Skills

Good Manufacturing Practice knowledge

Excellent IT skills

Analytical skills

Teamwork

Education

BSc in Chemistry or Pharmaceutical Science

Qualified Pharmacy Technician

Tools

Microsoft Office applications

Job description

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.

Responsibilities

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).
19. Resources Planning
20. Ensure all preventative measures are assigned with achievable timeframes.
21. Ensures that all change requests are assessed and processed in a timely manner.
22. Support where needed to NSM (Non-Sterile Manufacturing) with product release activity to ensure release of tablet packed products meet the required manager times.
23. Ensures that accurate computerised records are maintained to facilitate senior management decision making.
24. Contributes in identifying action plans to achieve cost savings within QC/QA/Stores.
25. Staff Management and Training
26. Helps to maintains staff awareness of QMS systems and ensures the system is efficient.
27. Participates in the training of staff in Quality Assurance and QMS.
28. Participates in presenting on a monthly basis to all section heads and senior management on the progress of the QMS using Microsoft software.
29. Documentation
30. Reviews Standard Operating Procedures within QA / Pharmacy Stores and the wider QMC AND CITY hospital sites, in accordance with the procedures.
31. Regularly reviews the training manual within the QA / Pharmacy Stores department
32. Assists in the maintenance of the quality document management system ensuring production, approval, issue and review of documents is performed in a compliant manner
33. Other Duties
34. Identifies and participates in training and development opportunities to support Continuing Professional Development.
35. 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.

Qualifications and Experience

Training & Qualifications

• Essential: BSc in Chemistry, Pharmaceutical Science or equivalent Science Degree, Qualified Pharmacy Technician or equivalent level of knowledge.
• Essential: Excellent IT skills, competent use of Microsoft Office applications.
• Essential: Demonstrates commitment to CPD in order to maintain QMS and QA knowledge and skills.
• Desirable: Specialist courses in Quality Assurance or related specialty.

Commitment to Trust Values and Behaviours

• Essential: Must be able to demonstrate behaviours consistent with the Trust's "Kind, Inclusive, Ambitious, One Team" behavioural standards.

Experience

• Essential: Specialist knowledge of Good Manufacturing Practice, Quality assurance and quality management gained through practical experience or post qualification training.
• Essential: Experience of managing deviations/incidents/CAPAs/change controls.
• Essential: Experience of investigative report writing and presentation of data to senior leadership team.

Desirable

• 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: Communicate specialist/complex information to an audience of specialist and non-specialist stakeholders.
• Essential: Demonstrated ability to influence senior staff, multidisciplinary teams and management.
• Essential: Demonstrated effective customer service skills, good teamwork, and effective remote communication with off-site units and agencies.
• Essential: Manage own workload, attention to detail, excellent verbal and written communication skills.
• Desirable: Excellent professional relationships with other Pharmacy teams including Production, Distribution, Radiopharmacy & Dispensary.

Analytical and Judgement Skills

• Essential: Ability to plan and prioritise work requirements and demands.
• Essential: Ability to identify problems, analyse root cause and propose solutions for complex problems, with ability to use initiative in problem solving.

Planning and Organisation Skills

• Essential: Able to plan, prioritise and organise self, and manage own workload.
• Essential: Working to instruction without supervision; meeting deadlines under pressure.

Physical Skills

• Essential: Ability to work in varying environments (e.g. laboratory, clean rooms, stores areas).

Other requirements specific to the role

• Essential: Able to promote and evaluate best practice within Pharmaceutical Quality Assurance Services; able to develop new systems of work.
• Essential: Ability to work to deadlines and meet objectives and targets.

Equal Opportunities and Additional Information

Disclosure and Barring Service Check: This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and a submission for Disclosure to the Disclosure and Barring Service may be required.

Certificate of Sponsorship: Applications from job seekers who require current Skilled Worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For more information visit the UK Visas and Immigration website.

Guidance on overseas criminal records checks can be found here: Criminal records checks for overseas applicants.

Employer details

Nottingham University Hospitals NHS Trusts

Queen’s Medical Centre, Derby Road, Nottingham, NG7 2UH

Employer's website: https://www.nuh.nhs.uk/