Validation Specialist
Current- PQ (Performance Qualification) & PV (Process Validation) with current manufacturing systems for NPI (New Product Introduction) at Bausch & Lomb Greenville South Carolina Facility.- Protocol Documentation of PQ and PV processes for NPI.- OQ (Operational Qualification) and PQ co-execution of New Tank Validation for “Bulk Department”- IOQ (Installation/Operational Qualification) protocol generation of Rockwell Software PCS System, execution of protocol with the engineering team ensuring system complies with all the FDA software system regulations.- Assure validation protocols run in accord with plant validation documentation protocols and challenge all the required manufacturing systems.