4 months ago
Would you like the chance to join an award winning global biotechnology Company who focus on development and commercialisation of innovative gene therapies to change lives? My client has a broad pipeline with one clinical trial ongoing and two more coming in 2019/20 which allows more opportunities to change lives of patients by providing directed gene therapy as a life-long and potentially curative treatment.
You will be given the freedom to lead QA duties in relation to clinical development functions to ensure that clinical trial operations team are given guidance following GCP requirements. Furthermore, this role will enable you to lead a team where you provide your expert guidance/training on GCP.
* You will be working closely with QA director to scope out the compilation of GXP audit plan and providing a continuous improvement environment.
* Must be able to conduct internal/external audits of GCP service providers ,QMS elements and selected GCP processes.
* You will be tasked on providing updates on QA at Clinical Operations project meetings
* Moreover, you will need to review SOPs, protocols, patient information leaflets investigator brochures, informed consent forms, and other participant and trial related documentation in compliance with GCP.
* Furthermore, must be confident in providing GCP QA input into Deviations, investigations, Change Controls and CAPAs.
* In this role you will need to provide your GCP training to colleagues to ensure a continuous improvement environment.
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be perfect fit for you.