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QA/QC Officer

4 months ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

Quality Assurance GMP Documentation/QA/QC Officer
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.
To support investigations into Out of Specification/Adverse Trend results obtained from environmental monitoring.
Reviewing WFI and microbiological environmental monitoring activities as required.
Reviewing EM data and preparing quarterly and annual environmental monitoring reports.
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
Quality Management and Documentation Control
~ 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 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 investigate patient complaints of Trust manufactured products.
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.
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.
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.

Degree in Pharmacy, Chemistry, Microbiology, Biology or other related scientific discipline


QA/QC Further education qualification e.g. Experience in the use and implementation of documentation control systems


Experience working in a Microbiology lab


Ability to write a report, analyse data


Guy's and St Thomas' NHS Foundation Trust
Thomas' NHS Foundation Trust