3-4

Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.

End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.

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

Granulation, Compression, FBE, Cyto, Sex Hormones Blister Packing - Primary, Capsule Hard Gelatine and Soft Gelatine.

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. 

Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents. Writers and edits clinical regulatory documents, including submission summaries and other complex documents.

Finished, Stability Section, knowledge of Instrument - HPLC, GC. Preferably know-how of Chromeleon Software.

Responsible to handle the team to achieve the set targets & maintain qualitative, quantitative as well as cGMP aspects.