Purpose Of The Role
To lead and deliver the greenfield OSD and Injectable manufacturing facility from concept to commercial operation, ensuring compliance with regulatory requirements, adherence to cost and timelines, and seamless coordination across all stakeholders.
Essential Duties And Responsibilities
- Overall ownership of project planning, execution, monitoring, commissioning and handover.
- Lead project feasibility studies, master planning, capacity planning and phasing strategy.
- Prepare, control and monitor project budgets, cash flow and milestone-based expenditure.
- Finalize project execution strategy.
- Review and approve basic engineering, detailed engineering and construction drawings.
- Drive procurement of long-lead and critical equipment.
- Monitor project schedules, risks, deviations and mitigation actions.
- Ensure compliance with cGMP, WHO, USFDA, EU-GMP and statutory norm.
- Interface with Manufacturing, QA, QC, RA, Validation, Finance, EHS and IT teams.
- Lead internal & external audits, inspections and regulatory readiness.
- Enforce EHS standards and safe construction practices.
- Manage change control, scope variations and contractor claims.
- Oversee commissioning, qualification, validation support and final handover.
- Build, mentor and manage project team.
