QA

Knowledge of global and regional pharmacovigilance regulations. Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.

Design, execute, develop, and optimize upstream process for biosimilars monoclonal antibodies, fusion proteins in CHO Cells. R&D USP Mammalian, R&D Analytical, R&D Bioassay

Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.

CVC Bottle Line Officer / Sr. Executive CVC Bottle Line. Inspection, Granulation, Compression & Wurster coater

Experience In Method Validation, Method Transfer, RM, OC, CLP, Investigation etc. Experience In Documentation, Qualification, Process validation

Monitoring of Aseptic Area / Environmental / Medical Fill \ Solution Preparation / Lyophiliization Operation / BFS and Infusion BAG filling.

Knowledge of BET, Environment Monitoring, Sterility, MLT, Culture, Media Preparation. Knowledge of injectable plant aseptic practices, Lyophilization, SVP/LVP Line etc 

Autoclave, Compounding, Filling Vial Washing, Lyophilizer. Instrumentation, IPFP& Stability. Safety, Training & Awareness, Documents & Compliance

Laboratory Quality Assurance Reviewer. Quality Assurance - Documentation Cell. Injectable / Parenteral / Sterile - Aseptic, Clean area, Manufacturing.