Executive/Senior Executive ? Project Management

Hetero; Sangareddy; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Hetero in India seeks a highly motivated Project Management Professional with 36 years of API/CDMO experience. The candidate will oversee projects from development through commercial manufacturing and coordinate with cross-functional teams and customers to ensure timely delivery.

The role requires handling technology transfer, process scale-up, validation batches, and collaboration with R&D, Production, QA, QC, Engineering, and Regulatory Affairs to meet quality and compliance standards globally.

Qualifications

• 36 years of API/CDMO pharmaceutical industry experience.
• Exposure to Technology Transfer (TSD), Production, QA, or QC.
• Strong knowledge of global regulatory requirements (cGMP, ICH, WHO-GMP, FDA).

Responsibilities

• Manage end-to-end projects from technology transfer to commercial manufacturing.
• Coordinate tech transfer, scale-up, validation batches, and production.
• Collaborate with R&D, Production, QA, QC, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure timely execution.
• Prepare and monitor project timelines, milestones, deliverables, and risk plans.
• Support process validation, cleaning validation, equipment qualification, and transfer documentation.
• Drive continuous improvement in project execution and operational excellence.

Skills

Project Management

Technology Transfer (TSD)

API Production

Quality Assurance

Quality Control

Education

B.E./B.Tech Chemical Engineering

M.Sc. Chemistry / Organic Chemistry / Analytical Chemistry

Job description

Job Summary

We are seeking a highly motivated Project Management Professional with 36 years of experience in the API/CDMO pharmaceutical industry. The ideal candidate should have exposure to Technology Transfer (TSD), Production, Quality Assurance (QA), or Quality Control (QC) and be capable of managing projects from development through commercial manufacturing while coordinating with cross-functional teams and customers.

Key Responsibilities

• Manage end-to-end project activities from technology transfer to commercial manufacturing.


• Coordinate technology transfer, process scale-up, engineering batches, validation batches, and commercial production.


• Collaborate with R&D, Production, QA, QC, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure timely project execution.


• Prepare and monitor project timelines, milestones, deliverables, and risk mitigation plans.


• Support process validation, cleaning validation, equipment qualification, and technology transfer documentation.


• Coordinate customer technical discussions, project review meetings, and manufacturing readiness activities.


• Track project progress and provide regular status updates to customers and management.


• Ensure compliance with cGMP, ICH guidelines, Data Integrity, EHS, and global regulatory requirements.


• Review project-related documentation, deviations, CAPA, change controls, and validation reports.


• Support customer audits, regulatory inspections, and internal quality audits.


• Drive continuous improvement initiatives for project execution, process optimization, and operational excellence.

Required Skills

• Experience in Project Management , Technology Transfer (TSD) , API Production , Quality Assurance , or Quality Control .


• Strong understanding of API manufacturing processes and commercial operations.


• Knowledge of cGMP, ICH, Data Integrity, WHO-GMP, USFDA, EU GMP, MHRA, PMDA, and other regulatory requirements.


• Experience in process validation, analytical method transfer, equipment qualification, and project documentation.


• Knowledge of deviations, CAPA, change control, risk assessment, and quality systems.


• Strong analytical, problem-solving, and decision-making skills.


• Excellent communication, stakeholder management, and cross-functional coordination abilities.


• Ability to manage multiple projects and deliver within defined timelines.

Qualification

• B.E./B.Tech Chemical Engineering or


• M.Sc. Chemistry / Organic Chemistry / Analytical Chemistry

Experience

• 36 years of experience in the API/CDMO pharmaceutical industry .


• Candidates with experience in Project Management, Technology Transfer (TSD), Production, QA, or QC are encouraged to apply.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.