Role & responsibilities

Project Planning & Execution

- Lead end-to-end project management for new API manufacturing facilities, plant expansions, and capacity enhancement projects.
- Develop and manage project schedules, budgets, timelines, and resource plans using tools such as Primavera or MS Project.
- Coordinate with consultants, architects, and EPC contractors for basic and detailed engineering, procurement, and construction activities.
- Drive installation, commissioning, and qualification (IQ/OQ/PQ) of process, utility, and ancillary systems.
- Ensure on-time delivery of projects within approved budgets and scope.

2. Engineering & Technical Oversight

- Review and approve Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs;), equipment data sheets, and layout drawings.
- Ensure engineering design adheres to cGMP, USFDA, EMA, MHRA, and WHO standards.
- Support technology transfer, process scale-up, and equipment selection in coordination with R&D; and Manufacturing teams.
- Provide technical leadership in areas such as utilities (WFI, clean steam, HVAC, chillers, compressed air) and cleanroom design.

3. Cross-Functional Coordination

- Collaborate closely with internal teams including Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement for smooth execution.
- Work with Finance and Procurement for cost estimation, vendor selection, contract negotiation, and budget tracking.
- Lead site-based project teams, ensuring effective communication, accountability, and goal alignment.
- Build robust relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery.

4. Compliance, Quality & Safety

- 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.

5. Reporting & Documentation

- 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.

Preferred candidate profile

Education:

- B.E./B.Tech/M.Tech in Chemical Engineering
- Project Management certification will be an added advantage.

Experience:

- 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.

Key Competencies & Skills

- Strong leadership and people management skills; ability to lead cross-functional teams.
- Excellent communication, negotiation, and stakeholder management capabilities.
- Strategic thinker with a hands-on execution approach.
- Strong analytical, problem-solving, and decision-making abilities.
- Demonstrated ability to manage budgets, timelines, and multiple priorities under pressure.
- Commitment to quality, safety, and regulatory compliance.
- Willingness to travel extensively (domestic and international) based on project needs.

Key Performance Indicators (KPIs)

- 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.

📌 General Manager - API Projects (Hyderabad)
🏢 Piramal Pharma
📍 Hyderabad