Competent in Analytical methods validations and transfers of Drug substances and Drug Products. Experience in drafting investigation reports and protocols
Candidate should have exposure in analysis of Content Uniformity, Blend Uniformity, Hold Time Study, Cleaning Validation Test and Finish Product Analysis.
Exposure of analysis for Finished Products, Stability Samples & Raw Materials. Having Knowledge of Analytical Method Validation, Verification & Method Transfer. Having skill for data interpretation, troubleshooting. Pharma knowledge of Solid orals & Quality process.
To perform all associate activities like reagent preparation, volumetric solution preparation, test solution preparation, factor determination, working standard preparation required for analysis as per approved procedure.
Executing chemical reactions in mg to gm scale and to synthesize required quantities of molecules/ compounds as per client specifications using efficient route and techniques
Hands-on experience in handling the complete life cycle from review, submission and queries to post approval of Topical, Dermatological Formulations. Adherence to high quality, and regulatory standards in dossiers.