Job Description

Position Overview

The

Assistant General Manager - Projects (API Pharma)

will be responsible for leading and managing end-to-end project activities for

Greenfield and Brownfield API (Active Pharmaceutical Ingredient)

manufacturing facilities across domestic and international locations. The incumbent will oversee all phases of the project lifecycle--conceptualization, design, engineering, procurement, construction, installation, commissioning, and handover--ensuring timely delivery, adherence to budget, and full compliance with

cGMP

,

EHS

, and

regulatory

standards.


This role requires a highly skilled project management professional with a strong background in pharmaceutical engineering, process design, and cross-functional coordination, capable of managing complex projects while driving excellence in quality, safety, and cost-effectiveness.

Key Responsibilities

1. 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 strong 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.

Qualifications & Experience

Education:

B.E./B.Tech/M.Tech in

Chemical Engineering

Experience:

Minimum

15+ 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

multi-location projects

(India and/or international sites). 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.