Job Description

Proactively contribute in Project Initiation, execution, Tracking, Monitoring, Troubleshooting and Facilitating activities till dossier filing. Accountable for the overall outcome of the project from Initiation to Completion. Closely work with US, EU, CA, ROW, Brazil Project managers ,Bridge between R&D and different territory Project manager Contribute to Project Initiation in Tool , Project budget preparation. Track and monitor actual vs. budget (cost, man-hours, material) for their optimum utilization To ensure R&D sourcing and Supply chain for API (IH & OSC). RLD, RM/PM, Equipment availability for R&D and Plant, BE studies (CROs) and prioritizing on projects. Provide necessary inputs for initiating the procurement process. Track, review & regulate the progress of the project to meet the deliverables. Compare target, planned and actual (Schedule/cost/quality), report the variance to stakeholders, Identify scope change in cost, schedule, facilitate on necessary approvals. Active participation in Annual Budgeting for R&D, and quarterly reviewing the BE budget of budget vs. actual costing and number of studies. Work closely with Plant TT, Plant QA, and QC for production schedule, monthly, quarterly and annual plans for manufacturing of R&D batches. Track RM release, AMV and TT, Micro validation leading to manufacturing of submission batches at OSD and Sanand. Track deficiency for solid orals and coordinate the priority for different analytical activities leading to deficiency response submission by RA for OSD and Sanand Use of appropriated tools to plan and execute projects from timelines, cost and quality perspective. Conduct timely meetings to keep track of ongoing projects and meet deliverables. PM Initiatives: Contribute in implementation of new initiatives in PM department, Coaching team members on Project Management practices. Planning tracking, monitoring and review of the execution of the batches at manufacturing sites OSD and Sanand, conducting weekly meeting to ensure the smooth functioning and availability of the requirements for batch execution. Compilation of Project closure report on completion of the project, implementation of project management tool for monitoring like variance analysis on timely basis.