Sr. Executive/Asst Manager

Job Description

Role & responsibilities Essential Duties and Responsibilities: Create detailed Project development plan, Timeline, cost, milestones, critical path along with resource allocation in line with business requirement for generic product development Communicate and align project team members in line with project plan on timelines, resources Manage license activities in coordination with regulatory team Manage and de-bottleneck logistic issues for availability of API, Innovator, Raw materials, test samples etc. as and when required to ensure smooth execution Ensure on time execution of Scale up/feasibility/Assessment/registration batches, bio studies, filing by conducting periodic review meetings with units Lead project stage gate meetings to review milestones, actual costs, provide weekly project status and escalate issues for deviation of scope Manage conflict and bring quick resolution to difficult problems through timely intervention and by facilitating and strengthening the interaction between CFTs . Track and drive regulatory and quality compliance requirements, deviation and change controls. Lead project risk mitigation workshop to identify risks involved to projects, prepare mitigation plan and ensure execution of the same. Ensure timely analysis and reporting to enable accurate information sharing . Lead project meeting with CFT member for project key decision . Ensure compliance to the operational excellence initiatives like 6 months planner for manufacturing batches in unit . Managing adherence to stage gate process. Provide detailed Project handover document to the deficiency/launch project managers post filing to ensure seamless integration Provide lessons learned during development of generic product post filing to CFTs Preferred candidate profile Share profile on priyanka.singh@alkem.com Perks and benefits Best for Right candidate