B.Sc

Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes

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

M.Sc, Microbiology, Biotechnology, Zoology, Botany from a recognized university or M.Sc. in life Sciences, Zoology, Botany, Marine Sciences, Chemistry, Environmental Sciences from a recognized university or equivalent.

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. 

Bachelors degree in life sciences or business. Experience in consulting management in the life sciences, pharmaceutical/ biotech consulting industry or equivalent industry role

Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.

Perform complex scientific study data review and management of CDM, Study Responsible Scientist SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities e.g., Coding, SAE reconciliation is possible.

Collecting and submitting in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples as per the respective procedures, batch manufacturing records and packing records, protocols. Conducting AQL inspections and periodic inspections of control samples