 Good Equipment Qualification experience in a cGMP environment (URS, DQ, SAT, FAT, IQ, OQ & PQ).  Have performed the Qualification of equipment, Reactor, Dryer, Centrifuge, Blender, RCVD, Process & Automation Systems Including purified Water System, HVAC system, ISO designed clean rooms.  Have prepared protocols independently, analyzed test results, and technical reports.  Ensuring the effective implementation of the best Quality Management Systems in the organization.  SOP Preparation and Review : Preparation and Review of Standard Operating Procedures. Evaluating gaps in the systems and addressing them accordingly.  Audits: Handling of regulatory audits and customer audits (foreign customers) and responding to customer comments.  Equipment Qualification’s: Preparation, Review & Approval of equipment qualification documents (URS, DQ, SAT, FAT, IQ, OQ and PQ). Formulate the validation master plan.