Harsha Enugandula

OBJECTIVES Result-driven and aggressive project manager looking for a suitable position, employing hands on experience in planning, analyzing and implementing assigned projects and ensuring delivery of projects within established constraints.

• Set up a parenteral R&D facility Set up an additional OSD facility in the existing R&D

• End to end project management activities: Initiating, planning, executing, monitoring, controlling and closing of assigned projects.
• Responsible to deliver assigned projects on time, within scope, within budget and with quality.
• Ensure availability of PIF from portfolio team before initiation of project.
• Preparation of project budget, costing & generating WBS code. To decide project timelines and monitor it throughout the project for timely completion.
• Creates and maintains comprehensive project documentation, including the project checklist, project plan/schedule, micro tracker, escalation matrix, project occupancy sheet, critical projects PPT etc. Organizing project kick-off meetings and stage gate review meetings.
• Coordinating with FD/RA/HR for licensing activities. Conducting regular project review meetings with stakeholders (internal and external) to monitor and control projects progress.
• Communicating the project status and updates to the respective stakeholders/customers on weekly/bi-weekly basis through email minutes/PowerPoint presentation.
• Conducting meetings with cross functional teams or external vendors to sort out issues for way forward.
• Tracking of monthly API forecast with the SCM/BD, maintain API requirements and summary sheets on monthly basis.
• Continuous risk assessment, identify and escalate any critical path delays which could impact product timelines.
• Conducting Spec meeting and publishing minutes.
• Continues support to the development teams by arranging necessary APIs, raw materials, impurities, RLDs, tooling, vendor documents etc, to facilitate smooth and on time delivery of projects.
• Preparation of scale-up and exhibit batches material procurement form. Coordination with plant team for execution of scale-up and exhibit batches and also ensure the API/raw materials/packaging materials, tooling, change parts, dosing discs availability.
• Maintaining and tracking of regulatory queries with respective stakeholders to ensure response within defined time-frame.
• Managing alternate vendor development for commercial projects to minimize cost.