Performing the periodical system washing of HPLC systems related to method development group. Responsible for calibration of HPLC and UPLC, 1C and dissolution apparatus.
Good knowledge on the scale-up factors from RD to EB scale pharmacokinetics of drugs, proficiency in BE studies is required. Experience in responding regulatory Queries for all markets
looking for an expert in Formulation development of Oral Solid & liquid dosage forms of regulatory markets. To coordinate with various CROs and internal Formulation R&D and Formulation Analytical R&D on the technical aspects of product development activities from development to filing stage.
Routine Analysis, Dissolutions, handling of HPLC /GC/ ICP-MS / AMT Activities. Should have thorough understanding of instruments Spraytec, SprayView, Cascad impactor, HPLC and Various detection systems like GC and UV.
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.