5M&E Analysis: Conduct comprehensive assessments of Man, Machine, Material, Method, Measurement, and Environment to ensure site readiness and process stability.
Project Management: Develop and maintain Gantt charts, timelines, and resource plans to track progress and manage dependencies.
Business Case Development: Build and present business cases to justify investments, including cost-benefit analysis, ROI, and strategic alignment.
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Work closely with Project Managers, Engineering, Construction, Procurement, Commercial, and other stakeholders to monitor project progress and support successful project delivery.
Consolidate project data and prepare management reports to support decision-making and executive reporting.
Monitor project risks, issues, and change requests, ensuring timely escalation and resolution where appropriate.
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•Adhere to company Program Management guidelines and project governance processes.
•Adopt to the project implementation SOP to develop, implement, and maintain a detailed project work plan, including appropriate controls, governance structures and monitoring to ensure on-time, on-budget, and quality outcomes.
•Responsible for providing progress reports/input on project status, capturing of risks and issues.
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Performs ongoing assessment and allocation of resources within study team to ensure balanced workload for quality administrative support
Ensures rCTMAs have the required level of administrative knowledge and skills to successfully deliver to protocol and study requirements
Is responsible for managing and addressing rCTMA performance and quality performance indicators, procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.
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Interface & steer cross-functional team engagements across Business Units, Central Engineering, Operations, Quality, Supply Chain and Procurement to meet department objectives
Drive DFM, technology & manufacturability readiness for new package & complex derivative platforms for effective POR freeze to new product industrialization
Partner with OSATs to deliver assembly readiness for new product qualification. Key activities include process flow & BOM setup, risk analysis & mitigation, process characterization, lookahead assessment, qualification and CAB preparation leading to first part release
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