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My client are seen as one of the top ten global biotechnology companies to watch in 2020, who have real focus on the development and commercialisation of unique gene therapies to change lives. They have a strong pipeline with two clinical trials ongoing and two more coming in 2020 which allows them to have a real chance to change the lives of patients by providing directed gene therapy as a life long and potentially curative treatment. This company are fully invested into their employees by providing professional development, flexible work/life balance and a chance to make a real-world impact.
This role will allow you to work very closely with QA Manager to deliver training for non-conformance, change control, CAPA and OOS system documentation. While also, providing advice/guidance to personnel on appropriate CAPAs. You will be responsible for managing PQS non-conformances, change controls, CAPAs and OOS system documentation which can allow a continuous improvement environment to be maintained.
You will play a vital role in the design of e-QMS work flows for non-conformances, change controls, CAPAs and OOSs documentation.
You will be asked to represent QA in meetings to provide relevant updates to ensure the company processes are being followed or improved.
Must be to coordinate timely review and progression of non-conformance - change control - CAPA and OOS system documentation.
Ensure that all systems used to monitor the progress of non-conformances, change controls, CAPAs and OOSs system documentation are sufficient and up to date. In addition, ensure that the relevant managers have clear visibility of pending/due non-conformances, change controls, CAPAs and OOSs system documentation.
Provide advice and guidance to personnel on appropriate CAPAs, while verifying completion of CAPA actions.
PQS Document Controller.
Must Educated to degree level or equivalent with a pharmaceutical related or biotech related degree.
Prior experience in the pharmaceutical/biotechnology industry, minimum 2-3 years QA experience.
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be a perfect fit for you.