1 - 5 years
3 - 6 Lacs
Posted:1 hour ago|
Platform:
Work from Office
Full Time
Job Purpose: To support and lead technical initiatives such as process scale-up, troubleshooting, and capacity enhancement in API manufacturing, ensuring smooth technology transfer and continuous process improvements for optimized productivity and quality. Key Responsibilities: Assist in process scale-up from R&D to plant scale, ensuring smooth technology transfer and implementation. Support and lead process troubleshooting to resolve deviations, yield losses, and quality concerns. Drive capacity enhancement initiatives through debottlenecking and cycle time reduction. Collaborate with R&D, production, QA, and EHS teams for process validation and continuous improvement. Prepare and review process documents such as PFDs, P&IDs, Batch Manufacturing Records (BMR), and SOPs. Monitor critical process parameters and support investigations for any abnormalities. Conduct data analysis and root cause analysis (RCA) to optimize existing processes. Participate in audits and regulatory inspections by providing technical justifications. Ensure adherence to cGMP, safety, and environmental standards during implementation. Support new product introduction (NPI) and pilot batches in coordination with cross-functional teams. Required Skills & Competencies: Strong understanding of chemical engineering principles and API manufacturing processes Hands-on experience in process scale-up and technology transfer Knowledge of cGMP guidelines , safety protocols , and regulatory requirements Proficiency in root cause analysis, process troubleshooting , and documentation Analytical mindset with strong problem-solving abilities Good communication and team coordination skills
MSN Group
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