Quality Assurance Officer

Job 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.

Training & Qualifications

Essential

• 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

• 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.
• Experience of managing deviations/incidents/CAPAs/change controls
• 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.
• 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

• Excellent professional relationships built with other Pharmacy teams; including Production, Distribution, Radiopharmacy & Dispensary

Analytical and Judgement Skills

Essential

• 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

• Able to plan, prioritise and organise self, and manage own workload
• Working to instruction without supervision, Meeting deadlines whilst under pressure.

Physical Skills

Essential

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

Desirable

• Ability to drive or otherwise travel between the locations of internal/external Trusts.

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
• Ability to work to deadlines and meet objectives and targets

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

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 further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).