Executive/Senior Executive - Project Management - (API/CDMO)

Job description

**Job Summary** We are seeking a highly motivated **Project Management Professional** with **3 to 6 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.