General Manager - Projects (API Pharma)

Ensure strict adherence to EHS (Environment, Health & Safety) and Quality Management standards throughout project execution.

Conduct Hazard and Operability Studies (HAZOP) , risk assessments, and implement mitigation strategies.

Ensure all activities comply with statutory, local, and international regulatory requirements.

Support readiness for regulatory audits and inspections related to project and facility setup.

Prepare comprehensive project reports , including progress updates, risk analysis, and deviation reports, for senior management.

Maintain accurate documentation as per GMP and project management protocols.

Track project performance against defined KPIs and milestones , recommending corrective actions as needed.

Present updates in management review meetings and provide visibility into project health and financial status.

B.E./B.Tech/M.Tech in Chemical Engineering

Project Management certification will be an added advantage.

Minimum 20 + years of experience in API or bulk drug project management , preferably with leading pharmaceutical companies.

Proven experience in executing Greenfield and Brownfield projects from concept to commissioning.

Exposure to Multiple Projects handling

Strong understanding of GMP facility design , process equipment , utilities , and HVAC systems .

Familiarity with international regulatory guidelines – USFDA, EMA, MHRA, WHO.

Proficiency in project management tools such as Primavera, MS Project , and AutoCAD .

Timely completion of projects within approved budget and scope.

Compliance with regulatory, safety, and quality standards.

Effective vendor and contractor management.

Achievement of project milestones and financial targets.

Stakeholder satisfaction and cross-functional collaboration effectiveness.