Project Manager - API/Oncology manufacturing experience

Role & responsibilities :

• Responsible for project planning, execution and completion of project as per timeline with engineering design , considering Safety , GMP and Good quality,
• Responsible for designing, installation and qualification of all production equipments, utilities including clean utilities (HVAC,purified water, AHU systems) and other utilities, which should match the sizes of process and production plans for all facilities planned which will be planned as per requirement of Company at various locations.
• Responsible for startup, ensure the progress and then completion of project within the target date.
• Responsible to assess and estimate the project cost ( equipment and facility ) based on components added in such project/equipment's and justification of such components and should be able to guide Management for such cost component .
• Responsible for making the design and qualification of equipment/ facility till the cost effectiveness is established and ensured.
• Responsible for designing of facility /equipment as per requirement of User , GMP, Safety factors ,other impacting factors of longevity of equipments and feasibility, either designed independently on own or through Consultant.
• Responsible for technical detailing of the facility including statutory approvals which includes document for consent establishment, consent for operation and operational parameters of process and utilities.
• Draft and submit the project proposals with budget, concept note and layout to management.
• Responsible for the site until Operational qualification of every system is done and ready for PQ.
• Delegate tasks and responsibilities to appropriate personnel at site during project work.
• Responsible for receipt, storage and correct utilization of project materials at site and accountability of materials at site.
• Estimate the resources needed to achieve project goals, request the same to management for approval and work /execute as per approval.
• Qualifications support for DQ, IQ, PQ & OQ for major & critical equipments.
• Cost estimation for Process equipments, Utility Equipments pipelines & fittings & control systems for Green field projects.
• Review of all AutoCAD drawings for new proposals as well old modifications to support the process.
• Commissioning of new process Equipments, Utility equipments, other supporting accessories.

Preferred candidate profile :Looking for candidates with green field projects experience for execution of maintenance work in API/Oncology manufacturing sector for upcoming new plant at Harohalli,Bangalore.