Executive - MSTG Sun Pharmaceutical Industries Ltd

5.0 - 9.0 years

0 Lacs

halol, gujarat

On-site

As an Executive in MSTG at Sun Pharmaceutical Industries Ltd, your primary responsibility involves executing technology transfers to Sun/CMO sites, overseeing scale-up processes, exhibit batches planning, and process validation. This requires effective planning and efficient utilization of resources such as manpower, materials, and machinery. You will be responsible for various documentation tasks including the preparation of new production introduction forms, scale-up reports, reviewing Sun/CMO Batch Manufacturing Records (BMR), developing sampling plans, process validation (PV) protocols, User Requirement Specification (URS) preparation, and Dashboard preparation. It is essential to ensure that products are manufactured and stored in compliance with relevant documentation to achieve the desired quality standards. Additionally, your role includes reviewing and providing comments on Master Formulae (MF), Failure Mode and Effects Analysis (FMEA), Risk Assessments (RA), and protocols such as Sampling plans and Process Validation protocols to ensure regulatory compliance. You will also be involved in handling and supporting troubleshooting batches for data comparison and root cause investigation at Sun/CMO sites, investigating product troubleshooting, and overseeing timely packing operations. Furthermore, you are required to monitor and conduct pre-checks on equipment planned for use in scale-up, exhibit, and process validation batches, including equipment preparation, vial washing and dehydrogenation, Clean-in-Place/Sterilize-in-Place (CIP/SIP) systems, Programmable Logic Controllers (PLCs), and various instruments. Your role also involves supervising and conducting skid trials to enhance product development, improve processes, and address potential manufacturing constraints effectively.,

Posted 1 month ago

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