Pratik Bhatt
Analytical Development Professional | Method Development & Validation | ICH, USFDA, cGMP/GLP Compliance | HPLC, GC, Dissolution Testing | Stability Studies & Cross-Functional Collaboration
- Role
- Assistant Manager at Senores Pharmaceuticals Limited
- Location
- Gandhinagar, GJ, IN
- LinkedIn followers
- 500 followers
About Pratik Bhatt
I am a highly experienced and dedicated professional with a strong background in the…
Experience
Assistant Manager
Senores Pharmaceuticals Limited
Aug 2022 — Present · Ahmedabad, IN
Oversee stability testing and ensure compliance with established protocols.Manage calibration records and ensure adherence to instrument compliance standards.Prepare and review specifications, STPs, and COAs for APIs and finished products.Coordinate method transfer activities and provide troubleshooting support for HPLC, GC, and dissolution testing.Track and manage data related to Test Request Forms, impurities, and drug samples.Liaise with vendors for procurement of chemicals and materials based on impurity data.Provide guidance and mentorship to team members, fostering a collaborative work environment.Notable Achievements:Streamlined the method transfer process, reducing turnaround time by 15% through improved coordination and documentation practices.Successfully prepared and submitted over 50 regulatory documents, including specifications and COAs.Implemented a proactive calibration schedule, resulting in a 20% decrease in instrument downtime and improved data reliability.Led stability studies for multiple drug products, ensuring all samples met ICH guidelines and supporting successful product shelf-life determinations.Collaborated with external laboratories for testing and reporting, ensuring timely delivery of results and maintaining product quality standards.
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