Purushothama Rao Eranki, known as Purush, is a seasoned professional in the pharmaceutical industry, currently serving as a Specialist in Quality Engineering QA at Taro Pharmaceuticals. With over a decade of hands-on experience in pharmaceutical quality assurance and validation across Canada and the USA, Purush...
Purushothama Rao Eranki, known as Purush, is a seasoned professional in the pharmaceutical industry, currently serving as a Specialist in Quality Engineering QA at Taro Pharmaceuticals. With over a decade of hands-on experience in pharmaceutical quality assurance and validation across Canada and the USA, Purush has honed his expertise in ensuring compliance with stringent regulatory guidelines, including HPFBI, cGMP, ICH, and US FDA standards. His role is pivotal in providing quality assurance oversight for all Good Manufacturing Practice (GMP) activities within the Engineering, Maintenance, Validation, and Production departments.
Purush's extensive skill set encompasses the development, execution, and review of critical validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for various equipment and utilities. His proficiency extends to the qualification of HVAC systems, Building Automation Systems (BAS), Regenerative Thermal Oxidizers (RTO), purified water systems, and compressed air systems. He is instrumental in reviewing and approving essential design documents such as User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and commissioning reports, ensuring that all processes align with industry best practices.
Currently, Purush is engaged in key projects that involve the validation of complex systems and processes, including thermal mapping of refrigerators and stability chambers, autoclave validation, and managing change controls. His commitment to quality is further demonstrated through his involvement in protocol deviations and non-conformance incidents, where he applies his knowledge of CAPA (Corrective and Preventive Actions) and Computer System Validation. Purush's dedication to maintaining the highest standards of quality not only enhances operational efficiency but also ensures patient safety and product integrity in the pharmaceutical landscape.
