CSV Technical Writer/Validation Executive would take care of creation and update/revision of all the current and ongoing Validation and SOP Documentation need for Software Applications/ERP. He would be an experienced resource in his/her job role. Should be aware of Computer System Validation according to 21 CFR part 11 and FDA regulations for IT Software Applications following the GAMP 5 guideline Should have good experience in writing GMP SOP and Validation Documentation work. Expert in writing/creating Validation Plan document, GAP Analysis document, Risk Assessment document, IQ, OQ, PQ Protocol writing and validation reporting. Should have writing Event investigation and closure reports.