ITI

FP / Stability / Analytical Instrumentation-HPLC, UV and Dissolution. Handling of LIMS, Empower software, HPLC Waters and SAP. Granulation Integrated line, Make-GEA / Glatt; Compression KORSCH, SEJONG, GEA, CADMACH; Capsule Filling; Liquid Manufacturing area

IPQA, Validation, QMS, Documentation, Compliance. Filling, Sealing, Autoclave, Compounding, Lyo, Visual Inspection, Vial Washing, Vial Collection, Vial Packing.

Candidate should have experience with the GEA Granulation line, compression processes in the oncology sector, and coating with Glatt and ACG equipment. Experience in handling regulatory audits is a must. Proficiency in English communication is required.

Candidate should be well versed with operation and maintenance of ointment manufacturing plant and handling PLC, SCADA. Handling of tube filling activity and packing activity of ointment, creams, lotions.

Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coaling, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will he added advantage. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer. Experience of GC, ICPMS and/or LCMS operation.

Depyrogenation tunnel, Filling Machine, vial washing Machine, Autoclave operation, Aseptic practices etc. Shift handling, QMS, External vial washing, Sealing Machine, Filling machine, Aseptic practices

Hands on Experience for handling critical lab instruments like HPLC, GC, Dissolution, UV Spectrophotometer, LIMS, FTIR , experience in Analysis of RM, FP and IP stability in QC.

Candidate must have 2-7 years of experience in production, including operations and supervision of autoclave processes terminal sterilization and components, filter integrity testing, aseptic and controlled area operations, as well as proficiency in vial washing and filling machine operations.