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.
Erp Computer System Cfr Cfr Part 11 Investigation Software Applications Plan Document Protocol Writing Assessment Document Gap Analysis
