Vikash Kumar Singh
Manager @Cognizant
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WORK HISTORY
Manager @Cognizant
Munich, DE
Provide senior Quality and compliance leadership for global pharmaceutical, R&D and biotech clients supporting manufacturing, laboratories, and enterprise GxP systems.• Lead CSV/CSA, data integrity, and Quality governance for LIMS (Labware, Lab-Vantage), MES/EBR, SAP, QC systems, and digital manufacturing platforms.• Drive Quality Management System implementation, risk assessments, Periodic Reviews, and GxP compliance strategies. • Oversaw audit readiness and defended validation strategies during FDA, MHRA, and TGA inspections. • Support facility establishment, qualification, validation, and operational readiness, embedding Quality expectations from early project phases.• Lead and manage a team of ~10 Quality and Validation professionals, including coaching, performance management, and capability development.• Develop and execute validation master plans, and lifecycle management processes aligned with Annex 11, 21 CFR Part 11, and GAMP 5.
EDUCATION
Visvesvaraya Technological University
Bachelor of Engineering - BE
ABOUT VIKASH KUMAR SINGH
Accomplished Quality and Validation leader with 15 years of experience in pharmaceutical, biotech, regulated R&D environments and medical device sectors, specializing in site-wide Quality Assurance (QA), Quality Control (QC), and computerized system validation (CSV). Proven expertise in driving cGMP compliance, QA remediation, implementing robust Quality Management Systems (QMS), and ensuring inspection readiness across manufacturing and laboratory operations. Experienced in leading cross-functional teams, developing strategic quality initiatives, and supporting regulatory inspections (FDA, EMA, MHRA, TGA) within global organizations. Skilled in digital transformation, risk-based validation strategies, and process optimization, fostering continuous improvement and operational excellence.
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