Job Description
- To lead site production and engineering projects. Act as project coordinator as a main responsibility and keep continuous tracking of projects. Must have proficiency / experience in the Microsoft project software and project tracking.
- Planning and follow up all new and retrofit projects of Oral formulations for the manufacturing site.
- Responsible for development of SOPs, quality standard, development,and execution of Qualification protocols with following site QMS procedures.
- Responsible for managing a team of vendors / contractors.
- Techno commercial evaluations of consultants, vendors, and contractors.
- Coordinating with statutory authorities for relevant approvals.
- Complying with operational and personnel standards, regulatory and statutory requirements to ensure efficient, reliable, and uninterrupted operation.
- Ensuring the best available technologies are incorporated by design.
- Delivering the project within the budget and timeline approved.
- Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.
- Ensure to maintain the highest standards for cGMP requirements for the manufacturing site.
- Ensuring timely MIS and updates to the management
- Ensure to meet required the regulatory requirements (e.g. HSA, FDA etc.) and keep the site audit ready all the time.
- Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.
Qualification
- Bachelor / master’s degree in engineering with a minimum of 8-10 years of relevant experience.
- Must be certified Project management professional.
- 5-10 years of experience in the green field / brown field area project management.
- Capability handles the project from USD 5-25 million.