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Glatt Systems is seeking a qualified professional to perform PQ/Exhibit validation and process optimization at customer locations in India. The role involves scaling up/down processes, conducting trials on R&D lab machines, and preparing value propositions for Glatt equipment.
You will coordinate with regional service and sales teams, publish detailed process reports, and train stakeholders on scale-up methodologies. Extensive travel to customer sites is expected.
To perform the PQ/Exhibit/validation at customer location considering scale up/down calculation
To perform process and product optimization, process improvement at customer location.
To conduct product trial on R&D lab machines
To make process proposal and value proposition on Glatt machine
To Identify and close the machine/process related challenges with coordination with cross functions
To conduct the training for internal and external stake holders on scale up/down, process optimization.
machine functions and operation and psychrometry
To publish the process report after visiting customer site
To coordinate with regional service engineer to get all machine/automation related issues closed.
To coordinate with regional sales head for any requirement for process support in the region.
To make databases for all products running on Glatt machines and update regularly
To conduct process study for various new requirements and to prepare proposals for value
"o attend monthly review meeting in Pune office to review the status of process achievements /open issues
in the given region.
To share learning/New idea /experience sharing during monthly meeting
To implement CAPA for any changes required in machine for optimum process output
To get regular feedback from customers in the given region and update to reporting manager
To provide visit summary reports weekly and monthly
Work experience from Formulation Development and Technology Transfer on granulation, Fluid bed, tablet coating, blending Is must.
Hands on experience in Handling and troubleshooting of various formulation on OSD machines
Good Knowledge on productivity enhancement tools.
Hands on experience on Palletization, Tablet coating technology. Various granulations technology and Blenders, Hot. melt technology, powder laying technology.
Scale up/down calculations
Good understating on Scale up/down philosophy of Various OSD's equipment's.
Shall have good knowledge about 21CFR, cGMP Documents in pharma industry. in
Understanding on psychrometry.