Planning of AMT, AMV, API verification & Review, overall GLP maintaining & compliance, Preparation of MOA and protocols, Coordination for TT & AMV, Must have knowledge of cGMP, GLP
Monitor on-floor QA activities, in-process checks, and documentation accuracy. Maintain control over qualifications, preventive maintenance, and calibration reviews.
Candidate should have demonstrated excellent technical and communication skills via presentations in conferences and publications in peer reviewed journals.
Require Analyst/ Reviewer with experience of API analysis using for Wet lab/ Stability / Inprocess Lab & Micro lab instruments like UV, Autotitrator, Muffer Furnance, IR, Potentiometer, Karlfisher, pH meter etc.
Experience in Production Liquid Manufacturing/ Granulation (Experience in Alexanderwerk Roll Compactor)/ Compression (Fette)/ Blister Packing (Elmach 3015) /AutoCartonator