Senior Quality Assurance Specialist
3 weeks ago
Myself and BioTalent have partnered up with a pioneering biotechnology company focused on developing novel cell and gene therapies, on their search for a Senior Clinical QA Specialist based at their London site.
As a Senior Clinical QA Specialist you will be responsible for ensuring the integrity and compliance of clinical trial operations and provide essential support, oversight, and act as the main point of contact for their laboratories engaged in exploratory analysis of patient samples.
You will be responsible for:
- Implementation of the company's quality management system relevant to GCP, including laboratory analysis of clinical samples, external vendor oversight, and training on quality procedures
- Acting liaison and support for Immunomonitoring and R&D labs, assisting in quality assurance aspects of the company's Clinical Trials
- Act as the system administrator for the eQMS, write and/or review QMS documents, including SOPs, deliver training to laboratory teams and eQMS users
- Plan and conduct of audits, including internal, vendors, clinical sites, and external laboratories
- Provide guidance on GCP/GCLP/GLP to clinical project teams
You will bring the following:
- Previous experience in GCP QA role, as well as working in Clinical laboratories
- Experience in Biologics, Steriles, CGT, or ATMP is highly desirable
- In depth knowledge of GCP and GCLP practices and regulations
- eQMS experience including implementation and administration
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