Hitesh Reddy

Computer System Validation Specialist @Astellas Pharma

San Diego, CA, US

Supported manufacturing operations team by preparing technical documents such as SOPs, qualification protocols, change controls, periodic reviews.>Coordinated with business team to prioritize projects according to business need.>Worked in a cross-functional team to support lifecycle qualifications, commissioning, and decommissioning of instruments and equipment in the laboratory.>Provided authoring support for investigations as needed.>Maintained a high level of error free, GMP compliant documentation.>Interacted with appropriate departments and individuals to accomplish work independently.>Supported Data Integrity Assurance Program for all documentation managed by our team.