Sr. Business Analyst

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• Develop a deep understanding of global Rapid Diagnostics distribution processes, systems, and business programs to identify operational risks, inefficiencies, and opportunities for improvement.
• Lead the creation, implementation, and continuous improvement of standard operating procedures (SOPs) and work instructions to ensure consistent, high‑quality operations across global sites and also involve in the documentation of the process.
• Oversee the implementation and maintenance of quality systems related to Rapid Diagnostics distribution, including documentation control, deviation management, CAPA, and change control processes.
• Ensure compliance with international regulatory standards, including FDA (21 CFR), EMA, MHRA, WHO GDP, and local health authorities, by aligning distribution practices with evolving global requirements.
• Foster strong cross‑functional collaboration with supply chain, quality assurance, regulatory affairs, legal, and commercial teams to support integrated compliance efforts and business alignment.
• Identify and lead initiatives to resolve process and system gaps that may impact product quality, regulatory compliance, or operational efficiency.
• Leverage and optimize distribution technologies, such as SAP, warehouse management systems (WMS), and monitoring tools, to enhance visibility, traceability, and performance.
• Collaborate with global partners, internal teams, and third‑party logistics providers to coordinate distribution activities, resolve challenges, and ensure timely, compliant delivery of Client products.
• Act as a liaison between business, regulatory, and technical teams, translating operational needs into actionable strategies and ensuring alignment across global operations.
• Author, review, and approve CSV and quality deliverables, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs.
• Optimize distribution and quality technologies such as SAP, Warehouse Management Systems (WMS), Win shuttle, and Docusign to enhance traceability, audit readiness, and operational performance while maintaining GxP compliance.
• Collaborate with clients to deliver demos and identify high‑value digital applications that support their business needs, while ensuring the design and implementation of solutions adhere to regulatory standards within GxP environments.

Associate

Contract

Research, Analyst, and Information Technology

Pharmaceutical Manufacturing

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