5+

Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.

To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.

Provides inputs for selection of the equipment Estimates the batch size based on available equipment at the receiving site. Assists in evaluating the suitability of partners development, manufacturing facility for technology transfer.

Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.

HPLC, GC, Physical and Chemical Analysis, QMS,RM,PM. Material Dispensing, RM Store, FG Store, Environment Monitoring, SAP, Inventory, QMS

Ability to conceptualize and drive large-scale marketing strategies with an execution-first approach. Experience in leading teams, collaborating with sales, and driving prescription demand at a national level.

Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review.