Technology Transfer

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.

To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes

Review and provide technical inputs on Product Development Reports, Master Formula Cards, and Technology Transfer documents

Experience in operating and supervising of Compression, Granulation & Coating i.e Fette,Glatt, Ganson, Imprinting etc.

M.Pharm, B.Pharm, M.Sc, B.Sc. Responsibility of Quality Control Laboratory Planning and co-ordination. Supporting timely release of samples as per production plan. Co-ordinating with PPIC team for daily manufacturing activities against the QC planning.

Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan

Must have worked in regulated plants having approvals of USFDA, MHRA. etc. Hands-on experience in handling and implementing cGMP Current Good Manufacturing Practice practices and Good Documentation Practices

To monitor the Demo, Scale up, exhibit, and launch batches. To take scale up batch, Exhibit batches and work on Trouble shooting. To perform investigation for Deviation/ OOS/ OOT observed at plant.

Analysis / Operation on HPLC/GC/FP/IP/RM/PM/Lab Monitoring. Environment Monitoring. Media Preparation and Autoclaving, MLT, BET, Sterility Testing. IPQA, QMS-Change Control. Investigation (Deviation / OOS / OOT). Market complaint. Cleaning Validation, AQA, Qualification of Equipment, Audit Compliance and Documentation.