Amandeep Singh Anand
Specialist @BioNTech SE
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WORK HISTORY
Specialist @BioNTech SE
Mainz, DE
Clinical Trial Supply Management• Managed global secondary packaging and labeling operations for Phase clinical trials, ensuring full GMP compliance and alignment with biotech and regulatory standards.• Reviewed and approved clinical label content; optimized documentation workflows in Veeva Vault to enhance audit readiness and cross-functional efficiency.• Coordinated Qualified Person (QP) release activities and maintained EU-compliant release documentation to support timely product availability for clinical sites.• Led expiry date management and relabeling programs, maintaining product integrity and ensuring uninterrupted clinical supply continuity.• Oversaw and authorized compliant destruction of investigational medicinal products (IMPs), labels, and packaging materials at CMOs.• Verified and approved CMO/vendor invoices against project scope and service agreements, supporting accurate cost control and contract compliance.• Created and maintained Product Specification Files (PSFs) for packaged and labeled clinical supplies, enhancing traceability and documentation quality.• Supported GMP investigations, deviations, and change controls in FORM-Guard, driving continuous improvement and operational excellence.• Maintained and standardized the English Master Label Phrase Library to ensure consistency and regulatory compliance across all clinical programs.• Authored, revised, and optimized SOPs and work instructions in Veeva Vault Docs, aligning processes with current GxP and industry best practices.• Mentored colleagues on clinical supply operations, GMP compliance, and best practices for documentation.• Utilized AI-driven analytics to monitor supply chain trends, forecast potential disruptions, and optimize supply management.
EDUCATION
Venkateshwar International School
High School, Sciences
Maastricht School of Management
Master of Science - MS, Business Administration and Management, General
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Bachelor of Technology (B.Tech), Mechanical Engineering
RWTH Aachen University
Master of Science - MS, Management and Engineering in Production Systems
ABOUT AMANDEEP SINGH ANAND
Clinical Trial Supply Management Specialist with Phase experience in GMP compliance, QP release coordination, labeling, SOPs, and CAPA resolution. Mentors colleagues and leverages AI-driven analytics to optimize global supply chains, mitigate risk, and ensure uninterrupted clinical supply continuity.
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