4-5

experience in global clinical trial support as a CTC / Project Coordinator. Experience in Phase 2 and 3 studies and global/international studies is advantageous.

Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols. SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports

Monitoring of Vial/ BFS/PFS /FFS /Isolator filling Line Operations and Experiences in Aseptic behaviour,Online Documents -cGMP

Having sound knowledge of Operation. Troubleshooting of QC Instruments & Investigation of OOS /OOT/Deviation. (e.g HPLC, GC, UV, FTIR, Polarimeter, UV-Spectrophotometer, KF, Apparatus)

Looking for suitable candidates for our US FDA approved OSD formulation facility at Paithan, Dist. Chhatrapati Sambhajinagar (Maharashtra)

Must have PhD, Medical degree or Master’s degree (MSc, M Pharm, Pharm D or equivalent) combined with relevant experience.

Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Handling of HPLC, GC, UV and Dissolution & other sophisticated instruments 

To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.