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Quality Assurance GMP Documentation/QA/QC Officer
| Posting date: | 13 May 2024 |
|---|---|
| Salary: | £42,471.00 to £50,364.00 per year |
| Additional salary information: | £42471.00 - £50364.00 a year |
| Hours: | Full time |
| Closing date: | 20 May 2024 |
| Location: | London, SE1 9RT |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9196-24-1227 |
Summary
Quality Management and Documentation Control To manage and maintain a documentation control system across the directorate and potentially across KHP. To support the implementation of Q-Pulse to manage the departments document control and quality management. To manage the transfer of documents from current filing system to the Q-Pulse electronic Quality Management System. To support the day to day operation of Q-Pulse. (Using Q-Pulse) to maintain version control of all GMP documents. To manage the review and approval process for all GMP documents. To progress the development and review of new and updated documents. To provide reports to Unit Managers on GMP documentation status and escalate any areas of concern to the QA Specialist for that area and the Head of Pharmaceutical Quality or Deputy. Quality Assurance To be part of the Quality Assurance team and carry out QA responsibilities as required, particularly in the Microbiology and Aseptics Units. To support the QA team in the delivery of the QA service, meeting the needs of the pharmacy department according to the requirements of the Medicines Act, and licenses held by the Trust. Assist the QA team in the development of the QA service. To provide expert advice on QA matters to all areas with particular emphasis on Quality Control, Microbiology and Aseptics activity. To assist in the drug defect investigations and drug recalls within the Trust. To investigate patient complaints of Trust manufactured products. To undertake validation reviews. To keep abreast of the latest QA guidelines. To write departmental procedures in line with current guidelines. To carry out log meetings with relevant units. To trend data from various Pharmaceutical Quality Systems and feed into Quality Management Reviews. To undertake internal audits for the QA service. With additional training potentially act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts. Microbiology To undertake duties as required by the Lead Pharmaceutical Microbiologist. To support investigations into Out of Specification/Adverse Trend results obtained from environmental monitoring. To support investigations into Out of Specification results obtained from Water for Injection (WFI) samples. To support the activities in the microbiology lab as required e.g. covering illness and annual leave. To write and update departmental procedures in line with current guidelines. Training new members of staff in aseptic behaviours in cleanrooms and introduction to microbiology. Reviewing WFI and microbiological environmental monitoring activities as required. Reviewing EM data and preparing quarterly and annual environmental monitoring reports. Development To investigate and implement the use of an electronic archiving system. To undertake continuous professional development. Training The post holder will assist in delivering the ongoing training programme for new users to Q-Pulse. Assist in the training programme for QA and QC personnel as required.