Job DescriptionCQR Expert – Clinical Supply Chain
NLocation: Mumbai/Bangalore/Coimbatore Compliance & Quality Management
N
n
Ensure clinical supply chain processes comply with GxP, GMP, GDP, GCP, ICH guidelines, and global regulatory requirements. N
Develop, review, approve, and maintain Quality Management System (QMS) documentation, including SOPs, work instructions, quality agreements, and compliance records. N
Establish quality governance frameworks and compliance strategies for clinical supply operations. N
Monitor quality and compliance metrics, identify trends, potential risks, and systemic gaps. N
Lead deviation investigations, change controls, CAPAs, root cause analyses, and effectiveness assessments. N
Maintain inspection readiness and ensure continuous compliance across clinical supply chain functions. N
Drive implementation and optimization of electronic Quality Management Systems (eQMS) and digital quality initiatives. N

nClinical Supply Chain Oversight
N
n
Provide strategicquality oversight for clinical supply planning,



forecasting, manufacturing, packaging, labeling, storage, distribution, returns, reconciliation, and destruction activities. N
Ensure compliance of Investigational Medicinal Product (IMP) lifecycle management across global clinical trials. N
Review and approve clinical supply chain documentation, procedures, protocols, and quality records. N
Ensure product traceability, chain-of-custody, chain-of-identity, and serialization requirements are maintained where applicable. N
Oversee temperature-controlled logistics and cold-chain operations supporting global study requirements. N
Support supply continuity planning and risk mitigation strategies to avoid disruptions to clinical studies. N
Collaborate with supplyplanning and operational teams to ensure compliant and uninterrupted product supply. N

nSupplier Quality &Vendor; Governance
N
n
Lead qualification, onboarding, periodic a

📌 Cqr Expert Bengaluru
🏢 Capgemini Engineering
📍 Bengaluru