Responsible for over all Production related work in API plant.
Responsible for scaling up the batches from lab scale/Pilot scale/Plant Scale to Commercial scale.
Designing & Selecting the proper equipments for the scale -up projects.
Validating the Batches of Pilot Plant & Commercial.
Cost Reduction during scale up of existing & new molecules.
Responsible for entire documentation during Validations. [Master Plan, Basis for Design, Equipment Equivalency etc.]
Equipment selection & Justification for Scale up from Lab to Pilot to Commercial site.
Optimization of Processes at Lab scale/Pilot scale.
Involvement in Selection of Raw materials & its Suitability for use in Commercial Scale.
Preparation of Trial Report, Validation protocol & Final Validation Report and to add as the Annexure in the DMF.
Handling various project activities including preparing PFDs & P&IDs ; preparing engineering drawing review of Chemical Equipments, conducting plant study and undertaking plant modifications activities for improving overall efficiency.
Solvent Recovery & Validation of Batches with recovered Solvents.
Achieving the Budgeted/Target RMC.
Complete Knowledge about Analytical data of the Products.
Work with cross functional teams to meet the departmental goals and objectives.
Licensing Applications for New Products (IEM : industrial Entrepreneur Memorandum DML : Drug manufacture License, LOP : License of permission).
Support for Launch Products, in terms of deliveries & Meeting the requirements.
Vendor Approval of the Raw Materials.
To ensure product delivery 'On Time and In Full' to cater requirements for various regulated markets.
Used SPC (Statistical process control) tools to determine & monitor the global database for GAP analysis (yield, RMC & recoveries).
Minimum Required skills:
Qualification: B.E/ B.Tech. (Chemical)
Location: Malanpur (Gwalior)
Key Skills: Understanding of GMP