Experiences in HPLC/ GC/ IR/ UV/ Dissolution/ Polarimeter/ Potentiometric titrations/ KF/ PSD by Malvern. Awareness on current Data Integrity requirements & cGMP requirements. Stability studies
Ability to collaborate effectively with cross-functional teams, including R&D, marketing, sales, finance, and regulatory affairs, to achieve project objectives and deliver end to end results.
Deviation and CAPA Support. Assist in documentation and tracking of deviations, change controls, and CAPAs. Participate in root cause analysis and follow-up actions.
M.Pharm Pharmacology. Literature search and designing of Bioavailability BA and Bioequivalence BE studies of oral and non-oral products - injectable, derma, ophthalmic etc. towards different regulatory submission.
Responsible and Accountable for Preparation / Compilation of registration, re-registration dossier and variation application as per registration guidelines for various countries.
Development of new extraction kits on various extraction platforms. Upgradation of existing products in view of attributes such as, but not limiting to performance improvement, cost reduction, new feature.
To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.