Venkata S Neerukattu
Assistant Manager Quality Assurance - Biologics Development Center @Dr. Reddy's Laboratories
Signup · Get unlimited contacts
WORK HISTORY
Assistant Manager Quality Assurance - Biologics Development Center @Dr. Reddy's Laboratories
Hyderabad, IN
Experienced in providing comprehensive CMC, Analytical, QA and CSV oversight within Product Development and R&D. Reviewed and authenticated CMC and product development documents for biologics including Rituximab, Abatacept, Nivolumab, Pembrolizumab, Bevacizumab, Tocilizumab, Trastuzumab, and Bispecific antibodies.Performed detailed review and approval of analytical methods for product characterization, functional assays, ELISA, binding assays, and PRI methods (HCP, HCD, PAL). Assessed method development reports, qualification/validation protocols, analytical similarity/comparability studies, stability/stress studies, specifications, and risk assessments.Ensured strong data integrity, traceability, GDP compliance, and supported regulatory readiness. Managed key QMS elements including deviations, change controls, incidents, investigations, CAPA, and annual trending. Conducted internal audits, lab rounds, and compliance checks.Provided QA oversight for CSV and equipment qualification, reviewing URS, GxP assessments, risk assessments, IQ/OQ/PQ, VSRs, traceability matrices, periodic reviews, calibration/PM, and decommissioning activities.Led SOP governance, training, and continuous improvement initiatives for analytical and computerized systems. Experienced with HPLC/UPLC (Empower), RT-PCR, UV-VIS, Capillary Electrophoresis, Maurice iCE, SoloVPE, SoftMax Pro, Gen5, Osmometers, Data Loggers, and various R&D systems.
EDUCATION
Indian Council of Agricultural Research (National Dairy Research Institute)
Master's Degree, Animal Biotechnology
Bapatla Arts and science college
Bachelor's Degree, Biotechnology
ABOUT VENKATA S NEERUKATTU
Quality-focused and compliance-driven professional with 12+ years of experience in the biopharmaceutical sector, specializing in CMC Quality Review, Analytical and Bioanalytical Assurance, Computer System Validation (CSV), and Data Integrity oversight across Quality Control and R&D environments. Demonstrated leadership in managing end-to-end QMS processes, analytical method governance, equipment qualification activities, and regulatory audit and submission support.Accomplished professional in CMC documentation review, GAMP5-based CSV lifecycle management, and laboratory systems governance, with a strong ability to collaborate across Analytical Development, QC, R&D, Product Development, and Regulatory CMC functions. Recognized for exceptional documentation accuracy, regulatory awareness, and the ability to build audit-ready, compliant laboratory systems. Supported major regulatory inspections including FDA, EMA, and MHRA with consistent excellence. Adept at strengthening compliance frameworks, enhancing data integrity practices, and driving continuous improvement across R&D and QC operations.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.