Practical experience as well as understanding of the legal requirements for validation and qualification. 2) Protocol preparation, execution of activities and report preparation for qualification and validation. 3) Qualification of process equipment for oral solid dosage forms, tablets and injectables. 4) Qualification of Quality control instruments 5) Preparation of qualification & requalification plans, the review of qualification and validation documents. 6) Process, clean room, and cold chain shipment validation. 7) CSV: Preparation of validation protocol, execution of activity and report preparation with conclusion for Computer System validation. 8) Understanding Quality Risk Management and risk assessment implementation during the course of the activity related to qualification and validation. 9) To conduct quality audit for vendor approval, gap analyses, internal audits, support regulatory audit preparation, and GMP compliance evaluation. 10) Had to have collaborated with a USFDA/EDQM-approved pharmaceutical company. 11) Investigation of OOS and Deviation to identify root cause, recommendation of corrective and preventative action and effective implementation of CAPA plan. 12) Review of QMS documents. 13) Skilled in providing training to every category of organization.
