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

Clinical Supply Chain Oversight
- Provide strategic quality oversight for clinical supply planning, forecasting, manufacturing, packaging, labeling, storage,



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

Supplier Quality & Vendor Governance
- Lead qualification, onboarding, periodic assessment, and risk-based oversight of CMOs, CROs, depots, warehouses, distributors, an

📌 CQR Expert – Clinical Supply Chain (Bengaluru)
🏢 Capgemini Engineering
📍 Bengaluru