Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Skills/Knowledge Required
Duties and Responsibilities
Perform risk assessments related to GxP process; determining the impact upon product quality, identifying critical process parameters
Execute qualification & validation tests, providing documented evidence a system is fit for purpose
Draft validation documentation, including protocols, reports and traceability matrixes
Conduct investigations into qualification failures, propose and then implement corrective & preventative actions
Maintain validation project documentation up-to-date, including providing updates to project schedules and related tracking sheets