Quality Assurance GMP Documentation/QA/QC Officer
2 weeks ago
This post is a Quality Assurance post specialising in Quality Management/GMP Documentation control and Quality Control.
The post holder be part of the QA team, they will manage the Quality Management and Documentation control systems across the directorate and potentially across Kings Health Partners (KHP) The role requires experience in QC in order to act as the lead QA support for the QC department. Main duties of the job To manage and maintain a documentation control system across the directorate and potentially across KHP. To support investigations into Out of Specification/Adverse Trend results obtained from environmental monitoring. To write and update departmental procedures in line with current guidelines. To support the day to day operation of Q-Pulse. To manage the review and approval process for all GMP documents. Reviewing WFI and microbiological environmental monitoring activities as required. Reviewing EM data and preparing quarterly and annual environmental monitoring reports. About us Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best-known hospitals - Guy's, St Thomas', Evelina London Children's Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation. We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark. We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research's biomedical research centres, established with King's College London in 2007, as well as dedicated clinical research facilities. We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally. We aim to reflect the diversity of the communities we serve and continue to develop new and existing partnerships with local people, patients, neighbouring NHS organisations, local authorities and charitable bodies and GPs Job description Job responsibilities 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.
- 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 latestQA 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.
- 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.
- To investigate and implement the use of an electronic archiving system.
- To undertake continuous professional development.
- 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.
- Degree in Pharmacy, Chemistry, Microbiology, Biology or other related scientific discipline
- QA/QC Further education qualification e.g. PTQA
- Experience in the use and implementation of documentation control systems
- Experience working in a Microbiology lab
- Ability to write a report, analyse data
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London, Greater London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full timeThis post is a Quality Assurance post specialising in Quality Management/GMP Documentation control and Quality Control.The post holder be part of the QA team, they will manage the Quality Management and Documentation control systems across the directorate and potentially across Kings Health Partners (KHP)The role requires experience in QC in order to act as...
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