Varun Parepally
Manager External Supplier Quality @Bristol Myers Squibb
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WORK HISTORY
Manager External Supplier Quality @Bristol Myers Squibb
Person In Plant (PIP) for CMO upstream and downstream unit operations like Single Use Bio-reactor (SUB), RM bioreactor, Cell expansion, 500L Single Use Mixer, TFF, Chromatography, Post column filtration, Bulk Filling, and Vial Filling for sLVV (suspension Lenti Viral Vector) production process.• Provided comprehensive Quality Assurance (QA) oversight across multiple external manufacturing and contract testing sites for Cell Therapy products, ensuring adherence to regulatory and industry standards, including FDA and EMA guidelines.• Developed and implemented supplier qualification practices using risk-based tools for assessments, qualification, and performance monitoring. Managed Quality Agreements, Quality Business Processes, Product Disposition, Deviations, and Corrective Actions in line with organizational strategies.• Actively participated in BMS’s External Manufacturing, Virtual Plant, and Analytical Teams to ensure consistent and collaborative communication with external manufacturing/testing partners.• Ensured that approved quality systems were established and maintained according to BMS quality standards and regulatory requirements, facilitating batch records review and release of vectors.• Provided QA review and approval for deviations, Out of Specification (OOS) results, investigations, Corrective and Preventative Actions (CAPAs), changes, validation documentation, enhancing operational deliverables and compliance.• Served as a QA oversight on Vector, Plasmid, and Cell Bank production teams, offering technical support and guidance to manufacturing partners and internal teams. • Supported internal and external audits, including Pre-License Inspections (PLI) and Pre-Approval Inspections (PAI), and led Inspection Readiness Activities at Contract Manufacturing Organizations (CMOs).• Supported KPI, metrics development, and other CMO Improvement Initiatives to drive enhancements in supplier performance and quality outcomes.
EDUCATION
Michigan Technological University
Master's degree, Chemical Engineering
ABOUT VARUN PAREPALLY
Experienced Quality and Validation SME, proficient in Supplier Quality Management with a focus on Quality Assurance, including roles such as CMO Person-in-Plant (PIP), Equipment Validation, Computer System Validation (CSV), and Process Validation within environments compliant with FDA 21 CFR Part 11, 210, 211, 4, and 820. My background includes extensive skills in Technical Writing, Validation Protocols, Quality Assurance, and Design Controls. I am dedicated to completing projects with a strong commitment to ethics and thoroughness. I aim to advance my career in the Pharmaceutical and Medical Device sectors, embracing the challenges presented by this evolving industry.• Led Quality Business Review presentations on a quarterly basis to review the KPIs for CMO suppliers.• Supported internal and external audits, including Pre-License Inspections (PLI) and Pre-Approval Inspections (PAI), and led Inspection Readiness Activities at Contract Manufacturing Organizations (CMOs) for sLVV (suspension Lenti Viral Vector)• Responsible for closing various Deviations and ensuring that proper disposition of products is taking place. • Performed GAP assessment in supplier controls and identified steps for remediation.• Proficient in performing comprehensive gap analyses and risk assessments in line with GMP, GLP, GCP, and 21 CFR Part 11.• Experienced in pharmaceutical equipment and process validation, including preparing and executing validation protocols (IQ, OQ, PQ).• Proficient in preparing and reviewing validation documentation, such as Validation Master Plans (VMPs), SOPs, validation protocols and reports.• Track record of ensuring compliance with FDA and other relevant regulations related to validation, such as GMP, GLP, and GAMP.• Hands-on experience in managing and conducting risk assessments, root cause analysis, and FMEA within the validation process.• Successfully completed 21 CFR Part 11 compliance assessments for both laboratory and manufacturing systems.• Experienced in executing IQ, OQ, and PQ for a variety of manufacturing equipment such as PLC, SCADA, and QC Laboratory.• Proven track record in developing validation master plans, IQ, OQ, and PQ protocols, and crafting summary reports.• Six Sigma Black Belt (UDEMY Course Completion Cert).• Authored Risk Management Documents like Hazard Analysis, DFEMA and PFMEA• Exceptional communicator with demonstrated relationship-building and interpersonal skills, capable of thriving in team-oriented settings.
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