Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility. Have good exposure in Sterile IPQA & Sterile Qualification Related activity.
As per the batch manufacturing procedures and packing protocols, samples such as in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples should be collected and submitted
Having Injectable Experience of Analysis of raw material. In-process, Finish products, Stability testing, Process validation. Hands on Experience of HPLC, GC, LBPC, Osmometer, KF Auto titrator and UV - Visible spectrometer, LIMS,QMS,Participate in Lab incident , OOS, OOT, Analysis of deviation.
Experience of formulation plant and knowledge of GLP & GDP. Should have knowledge of Microbiological testing, Environmental monitoring, Water system analysis, HVAC validation, QMS
Perform chemical and physical analysis of raw materials, in-process samples, and finished products. Operate analytical instruments like HPLC, GC, UV Spectrophotometer, FTIR, Dissolution apparatus, etc. Conduct stability studies and routine sampling/testing as per SOPs.
Ensure that Bulk Viral Antigen production adheres to GMP standards on the shop floor, including line clearance, dispensing, and preparation processes. Examining and approving batch records, standard operating procedures, project plans, customer verification, and APS documents.