Our client is a biopharmaceutical company that focuses on sterile injectable products. They are currently in need of a CSV SME to oversee all aspects of a quality systems upgrade. Our client is currently in the process of implementing a new quality management system and needs support from a CSV SME to oversee aspects of data integrity for the implementation. This person will be working with the IT team and managing activities to move data from current system to the new software. Ideally, this person will have experience with CFR Part 11 compliance, GAMP experience and authoring validation protocols. Additionally, this person will execute currently protocols to adhere to current FDA guidelines. Associated topics: diet, food, food scientist, health, healthcare, immunohematology, pharmacology, protein, trauma, vaccine
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