Hyderabad, Telangana, India
With over a decades of experience in the pharmaceutical and bio pharmaceutical industry, I currently serve as Head of Biologics DS Operations, Technical Operations, MSAT, and Transformation at Dr. Reddy's Laboratories. My expertise includes API manufacturing, industrial safety, and implementing operational excellence in biologics manufacturing. I have a proven track record in Good Manufacturing Practice (GMP), new product introduction, and MES implementation, with a strong focus on driving continuous improvement and fostering team development. Dedicated to advancing healthcare solutions, I aim to contribute to delivering innovative and life-saving medicines.
Responsible for: o As a start-up facility and I am responsible for New product introduction to the site from R&D o Initiate necessary change control to implement new product to the site o Create SOP for the new process and train the manufacturing associates. o Collaborate with Corporate team to ensure that Global procedures are complying with local standards/equipments. o Lead the team to create Master Batch record and E-log books in MES. o Co-dorinate with MBR designers to Create Batch records and Log books in MES in order to ensure the continued operation. o To work with Information system/Automation team to set up Delta V programs synchronized with MES in order to fulfil the process requirements with compliance manor. o Handling Non-Conformance, perform investigations, CAPA/CAPA EVs using Trackwise systems. Leading the team of engineers for handling the above mentioned areas. o Lead the team to Perform Root cause Analysis (RCA) for the deviations and ensure that the Manufacturing support team are trained and performing the investigations on right path. This is to ensure that MFG support teams are fully trained. o Lead and Involve trouble shooting during plant issues o Perform internal Audit and keep ready for Compliance Audit anytime by identify and address the deficiencies on the floor. o Handling and leading changes through change controls using Trackwise systems. Highlights: • Played a key role in managing training for all the team members in MFG support team to ensure that all the investigations are taking place on time with correct RCA identified and closed before the due date. • Played key role as a team lead to ensure that manufacturing MBRs are submitted on time to QA for Closure and on time batch disposition by QA • Develop high performance teams • Drive continuous improvement to increase productivity and efficiency per functional metric • Mature safety awareness and ownership culture