Sr. Business Analyst
Katalyst Healthcares and Life Sciences
Roles & Responsibilities:
- 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.
- ct as a liaison between business, regulatory, and technical teams, translating operational needs into actionable strategies and ensuring alignment across global operations.
- uthor, 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.
Vacancy posted 4 days ago
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