USV limited

Aseptic Filling operation for Vial filling, Ophthalmic filling & PFS filling machine, Autoclave, Vial Washing, depyrogenation Tunnel. Product filtration. Experience of USFDA approved sterile facility only.

Experience in OSD equipment including RMG, FBD, FBP, and machines from Gansons, Sejong, Glatt, Fette, suitable for a supervisor role

Expert in FG Analysis on HPLC, Dissolution, FTIR experience of USFDA approved OSD Formulation facility only. 

Proficient in microbial cell culture. Media Preparation in Upstream Production. Proficient in Downstream Production in a Microbial Facility.

Validation professional with expertise in qualification / validation / re-qualification of instruments, equipment & utilities; hands-on validation through electronic systems; calibration & preventive maintenance.

Responsible for FG testing, stability studies and analytical validation. Handling in-process QA, line clearance and compliance monitoring

B.Pharm, M.Sc Chemistry ; Basic knowledge of instruments HPLC, UV, IR, pH meter. Understanding of GMP, SOP, ALCOA+ principles, and Data Integrity.

Support in sampling and testing of raw materials, finished products and stability analysis. Documentation: Maintaining accurate, real-time records of all analysis as per cGMP and GLP guidelines.

Operation of Blister machines. Troubleshooting, BQS Cartonator: Operation of Cartoning machines. Troubleshooting