Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to improve the lives of patients around the world.
From the translation of preclinical to clinical, through commercialization, our expert scientists collaborate with you to optimize your therapeutic development and obtain critical insights earlier. We help accelerate your therapies through the development of highly specialized custom assays, deep biomarker expertise, and a passion for scientific innovation across complex therapeutic areas. Our global network of leading, specialty laboratories ensures you have access to quality data and can reach your patients. Together, we’ll improve patients’ lives around the globe.
The role of QA CSV Manager
WHAT WILL YOU BE DOING?
As an integral member of the QA team the role holder will be expected to provide advice on all aspects of GCP to support the quality, data integrity and safety of services provided by Cerba Research.
You will be contributing to the Quality oversight of reviewing and approving computer system validation activities ensuring compliance with FDA, EMA, GAMP 5, and internal policies. Independently review lifecycle validation documentation and system changes.
Assist in driving validation project completion, incorporating quality by design principles, supporting computerized systems investigations, and participating in internal and external audits as a quality specialist.
Further, you ensure a consistent approach to qualification, change, and deviation management across systems. Utilize modern QMS tools like Veeva, MasterControl, and Trackwise to maintain high standards of quality.
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