Job DescriptionCQR Expert – Clinical Supply Chain
nLocation : Mumbai/Bangalore/Coimbatore Compliance & Quality Management
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- 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
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- Provide strategic quality 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 supply planning and operational teams to ensure compliant and uninterrupted product supply.n

nSupplier Quality & Vendor Governance
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- Lead qualification, onboarding, periodic assessment, and

📌 CQR Expert (Vasanthanagar)
🏢 Capgemini Engineering
📍 Vasanthanagar