Detailed job description and main responsibilities

KEY JOB RESPONSIBILITIES 
Quality Assurance
1. To act as a Releasing Officer responsible for the approval or rejection of raw materials, intermediates, hospital manufactured finished products, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records on the LIMS system and generation of Certificates of Conformity and Certificates of Analysis for external clients.
2. As a Releasing Officer responsible for the review of documentation and physical stock in the Production Units, and release or rejection of batches for sale or use within the trust.
3. Responsible for the approval or rejection of all purchased non-licensed pharmaceuticals, and for writing their testing specifications, under the direction of the Head of Quality and Quality Assurance Manager.
4. To evaluate batch manufacturing records and batch packing records, alongside Quality Control test results, prior to release or rejection of a batch.
5. To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, 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.
6. To assist in ensuring satisfactory maintenance of the Quality and Production department, premises and equipment is carried out.
7. Responsible for setting up and maintaining maintenance contracts for all gas and particulate monitoring and office equipment.
8. To assist in ensuring that appropriate validations and competency assessments are carried out, including Production and Quality processes and procedures, assay methods and shelf lives and that the resultant reports are written.
9. To approve written, or amended, Pharmacy and Radiopharmacy Procedures, Master Batch Manufacturing Records and Batch Packing Records, which either directly or indirectly relate to licensable activities.
10. To assist in ensuring the manufacturing environment and equipment is monitored and calibrated, to ensure compliance with local and regulatory guidelines.
11. Responsible for the organisation of the environmental monitoring programme, which includes all the hospitals and commercial establishments for which we provide a service.
12. In conjunction with other staff responsible for carrying out the environmental monitoring programme, at the establishments for which the laboratory provides a service.
13. To help approve and monitor manufacturers of unlicensed pharmaceuticals.
14. To carry out regular internal audits to ensure compliance with GMP and to be involved with internal and external Inspections to ensure H&S and Regulatory compliance.
15. To assist the Head of Quality and Quality Assurance Manager in setting up Technical Agreements with internal and external clients.
16. To assist the Head of Quality and Quality Assurance Manager in providing quotes to new and existing clients, and ensuring funds are generated and invoiced.
17. To check completed Radiopharmacy worksheets for accuracy and QA Approval.
18. To attend regular Quality meetings to maintain Quality Assurance within the Production Units, and monitor progress against internal and external Inspections. Quality Assurance Support to Quality Control Laboratories and Production Departments
19. To ensure all work in the laboratories is carried out in compliance with the Health and Safety policies and Good Laboratory Practice, under the direction of the Head of Quality and Quality Assurance Manager.
20. To assist in ensuring satisfactory bonding, storage and stock rotation of raw materials and finished products used in the Pharmacy Production and Quality Control Departments.
21. To ensure all necessary testing is carried out, according to the approved written specifications or Pharmacopoeial monographs.
22. To review microbiological testing results from all units covered by the laboratory, and to initiate action with the Production Manager if results are outside of recommended guidelines. Also generation of comprehensive reports to be forwarded to the Production Managers, and responsible bodies, with recommendations for improvements where needed.
23. To approve specifications, sampling instructions, test methods and other Quality procedures.
24. To retain reference samples and documentation, to ensure compliance with GMP, and Regulatory Guidelines.
25. Assist the Head of Quality and Quality Assurance Manager in the management of the technical staff in the Quality Department at the QMC Campus.
26. Responsible for collecting and reviewing management information as required by Head of Quality and Quality Assurance Manager, in maintenance of the Pharmaceutical Quality System.
27. To ensure that all Quality personnel receive adequate initial and continued training and that this is adapted according to needs identified during staff appraisal.
28. To carry out appraisals with staff members.
29. Act as an authorised signatory for the Quality departmental budget.
30. To ensure the Quality and Production Department meets the clients deadlines, and levels of services agreed.
31. To support the Head of Quality and Quality Assurance Manager in the recruitment and interviewing of new staff.
32. Member of the department Management Review Team
33. To be familiar with the chemical and microbiological testing carried out in the Quality Control Laboratory.

Health and Safety
34. To assist in ensuring all staff in the department receive appropriate Health and Safety training and in monitoring the implementation and effectiveness of Health and Safety measures in the laboratory.
Medical Gases
35. To act as a Quality Controller (MGPS) in accordance with Health Technical Memorandum 2022 with responsibility for testing and certifying the Medical Gas Pipeline Systems at CHN, QMC, and other 
establishments under the fund generating contracts.
36. In conjunction with other staff on the Medical Gas QC Register to provide out of hours cover for emergency Medical Gas Testing for the CHN and QMC. 

Training
37. To prepare and present Tutorials and Training sessions, both within the Department, and externally as required.
38. To attend relevant training courses, and participate in CPD as appropriate.
39. To participate in competency checks within Pharmacy Technical Services, as appropriate, e.g. Environmental 
Monitoring, and Release of Products.
40. To be responsible for the competency checks of QC/QA Staff, and assessment before signing off Training Records.