Executive - API Technology Transfer

Role & responsibilities

• B. E/ B tech Chemical : Minimum 6 Years of Exp in API tech Transfer process
• Preliminary process discussion with R&D to foresee any issues with respect to process and to provide suggestions on process parameters as per, scale up
• point of view before lab validation batches if any.
• Queries and suggestions to R&D based on process write-up to get clarification
• on process Preparation of Quality risk management, equipment feasibility, equipment equivalency, utility calculations for all exhibit steps/products.
• Raw material consumption coefficient calculation.
• Lab demonstration and scale up parameters study.
• To identify the process issues in terms of operation, scale-up, safety and QA & RA guidelines.
• Safety discussion during demo along with R&D and EHS.
• To review lab demo results and circulation of demo observation report
• Revising the batch planning based on lab demo observation and circulation of the batch planning.
• Preparation of list of modification and the cost calculation.
• Follow up for raw material availability, pre exhibit meeting, use test, demo,
• exhibit batch startup, modification trial, HAZOP compliance, batch execution and completion as per scheduled time and dispatch etc.
• To do HAZOP study along with team members from production, R&D, safety and to ensure PDF (process documentation file) is completed as per process safety guideline.
• Execution of exhibit batches and its monitoring and to resolve scale up issues if any.
• Hardware modification for exhibit batch execution.
• Capacity calculation.
• Execution of first three production batches during commercialization.
• To ensure various promotion campaigns are arranged for promoting
• Environment, Health & Safety management system.