Chinna A.
About Chinna A.
Chinna A. is a Lead Validation Engineer I at Alkermes with extensive experience in validation and quality roles across the pharmaceutical industry.
Title and Current Role
Chinna A. holds the position of Lead Validation Engineer I at Alkermes. In this role, he works on-site in the United States, leading various validation-related tasks and projects. His responsibilities involve the development of validation content and controlled documents to support risk assessments, validation operations, and the maintenance of site GMP systems.
Previous Work Experience
Chinna A. has previously worked with several prominent companies. At Pfizer, he served as a Process Validation Specialist (SME) from 2021 to 2023 in Michigan. Prior to that, he was Quality (BPR)/Validation(Process) Lead at Catalent Pharma Solutions in BWI for 9 months in 2020. From 2018 to 2020, he served as Sr. Quality/Manufacturing Engineer (Team lead) at Abbott in Plano, Texas. Chinna's experience also includes roles at Zimmer Biomet and United Pharma Technologies Inc, where he worked as a Validation Quality Sr Engineer and Validation Specialist, respectively.
Education and Academic Background
Chinna A. has pursued extensive education in the field of biotechnology and management. He achieved a Master's degree in Project Management at the University of the Cumberlands. Additionally, he earned another Master's degree in Cell and Molecular Biotechnology from the University of Houston-Clear Lake. He holds a Bachelor's degree in Biotechnology from GITAM Deemed University.
Skills and Expertise
As an expert in the field, Chinna A. possesses significant expertise in laboratory analytical techniques, microbiology, and molecular biology techniques. He serves as a subject matter expert for equipment, facility, and utility qualification. He also leads and participates within cross-functional teams to complete various validation tasks and projects, demonstrating his comprehensive knowledge and skills in validation processes.
Validation Documentation and Process Management
Chinna A. is responsible for authoring, reviewing, and approving validation documents for systems and projects of varying complexity. He ensures that these documents are prepared from approved templates and in accordance with Standard Operating Procedures. His role involves significant contributions to the development, operation, and maintenance of site GMP systems through meticulous validation documentation.