Development of the project charter and management plan.
Direct, manage, monitor, and control project. Evaluate tradeoffs within project.
Collaborate with project stakeholders to develop, manage and own project scope.
Develop and manage the detailed project Gantt chart. Analyze critical path, major workstreams, and intersecting milestones.
Collaborate with cross-functional managers to define project budget. Monitor and maintain costs within budget.
Develop a risk management plan for the project. Identify, analyze, and understand project risks; develop and monitor a risk response plan.
Develop a Procurement Management Plan and collaborate on the selection of procurement partners.
Participate in the development of the validation and verification plan of the manufacturing processes at the vendor sites
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers.
What you will need:
Required Qualifications:
B.Tech./ M.Tech./ MS. - Mechanical/ Biotech Engg. / Electrical/ Electronic or relevant discipline or equivalent technical experience is required.
9 – 13 years of relevant Experience.
Proven Project Management skills through the delivery of business-critical projects.
Strong communication and influencing skills with both internal and external stakeholders.
High level of PC Skills required. (MS Excel, Access, PowerPoint, MS Project, PowerApps, Power BI dashboards).
Experience of GD&T, Process mapping, statistical methods and process/ product validations, PMP certification would prove beneficial.
Preferred Qualifications:
PMP or equivalent preferred
Capable of providing technical leadership and, influencing and providing technical direction to Engineers, Technicians and Operators as required.
Demonstrable strong analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment
Experience in an FDA regulated or regulated industry beneficial.
Confident and effective decision maker, with a proven technical leadership ability to negotiate and influence others.
