· Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market · Preparation of query response of drug substance fo...
Core responsibility related to GLP: Study Personnel (Toxicology & Efficacy studies) - Record raw data accurately and directly and in compliance with Principles of GLP during conduct of activity, verify the data collected, prepare reports an...
Follow cGMP and GLP practices in Quality Control Lab. • To analyze the Sample of raw material on non-chromatographic instrument such as FTIR, UV, Polarimeter, KF, Autotitrator etc. by following test procedure. • To attend the training as pe...
To lead the Granulation department with respect to developing the second line. • To ensure the delivery of products as per the production target. • To ensure and monitoring yield, Wastage, WIP & operation expenses of Granulation area. • To ...
- Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Biologics - Performing the production activities of Biosimilar Drug Substance - Operation of 5L, 100L and 150...
To perform the Technology transfer of Product from R&D to Site. • Receiving activities and QMS related activities at the manufacturing plant. • To perform alternate vendor batch execution, process improvement, change in batch size, trouble ...
Strategic Procurement: Develop and implement procurement strategies aligned with organizational goals. Lead cost reduction initiatives and supplier consolidation efforts. Identify new sourcing opportunities to improve cost, quality, and lea...
Strategic Procurement: Develop and implement procurement strategies aligned with organizational goals. Lead cost reduction initiatives and supplier consolidation efforts. Identify new sourcing opportunities to improve cost, quality, and lea...
"• To operate the CVC Bulk packing machine as per the norms of cGMP • To supervise the machine activity as per the standard output with GMP requirements • To carryout in process checks during packing machine activities • To arrange packing ...
Working in tablet granulation area as an operator and responsible for whole Granulation activity. • Operation & Cleaning of the respective Granulation machine hand over by shift in charge or any supervisor of Granulation area as per SOP. • ...