Dedicated and results-oriented QA Validation Consultant with a proven track record in the Bio-pharmaceutical industry. Currently contributing expertise as a Contractor at Regeneron in Ireland, specializing in the Generation, execution, and review of cleaning validation protocols, summary reports, and supporting documents. Proficient in executing cleaning validation samples procedures alongside Upstream and Downstream Processing, ensuring adherence to CIP/SIP timelines.With a background as a DP Specialist at Dr Reddy's Laboratories, Hyderabad, India, I possess comprehensive experience in planning and executing aseptic process simulations for Formulation and Filling activities and cleaning validations, and Involved in Executing Equipment validation, process validations for various drug products. Skilled in executing performance Qualifications of Autoclave, Vial washing machine, Tunnel Sterilizer and Filling machine. A hands-on expert in buffer preparation, formulation, and filling activities for products like G-CSF, Rituximab, T-Mab, and B-Mab.As a Senior Executive in Blending at Biological E, Hyderabad, I successfully managed the sterile blending of liquid vaccines and played a pivotal role in the facility upgradation of process area ( Grade-A, B, C & D). Proficient in handling blending vessels, cartridge filtration systems, and CIP/SIP systems, ensuring adherence to preventive maintenance, calibration, and sterilization protocols. Proven capabilities in process simulation, validation activities, and batch record review.My journey as a Senior Officer in DS & DP at Indian Immunological Limited involved handling semi and fully-automated bioreactors and demonstrating proficiency in CIP, pH, and SIP processes. Skilled in aseptic techniques, sampling, and bio-safety cabinet handling during the initial stages of cell culture. Experienced in downstream processes, including UF/DF filtrations and chromatography skid operations.Throughout my career, I have actively contributed to the design and execution of master batch records, business process flows, and SOPs, showcasing a commitment to operational excellence, regulatory compliance, and continuous improvement. I bring a wealth of knowledge in cleaning validation, process and equipment validation, and aseptic techniques, making me a valuable asset in the pharmaceutical and biotechnology sectors. Let's connect to explore potential collaborations and share insights in the dynamic field of pharmaceutical quality assurance and validation.
