Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
Bachelor's degree in Pharma, Life Science ; Drafting and Quality Review of safety reports like PADER, PBRER, PSUR, etc. Preparation and tracking of Aggregate report schedule. Understanding of country specific templates.
Apply knowledge of purification techniques at gm to kg scale Focus on delivering projects from initiation to completion Collaborate effectively with the team
Online filling of the BPRs and records and performing jobs related to SAP, Operate equipment's reactor, Sparkler Filter, Candle Filters , Centrifuge, Dryers as per SOP
M.Pharm / M.Sc. jobs; Analysis of Finished product, Method development, validation, Documentation as per GLP Stability analysis of finished products, calibration of instruments
Assists Head-Bioanalytical in the smooth running of the bioanalytical section through efficient project and quality management in conformance to GLP guidelines.