kunjan sompura

executive - corp quality it

About

Have experience in CSV for quality and manufacturing instrument. Well aware with regulatory requirement for computerized system. Expertise in computer system Validation as well as good knowledge of compliance practice and regulations(GAMP 5, 21 CFR part11, Annex 11, cGMP and 21 CFR part 210,211 etc). Have knowledge of QC software Troubleshooting. Well aware to define procedures and policies to computer systems.

Country

india

City

vadodara

Industry

pharmaceuticals

Skill

plc, scada, test automation, 21 cfr, gamp, gxp, computer system validation, engineering, electronics, 21 cfr part 11, validation, sop

Experience

validation engineer

epitome technologies

2012-12 - 2013-5 · 6 mos

Experience in overall Life cycle of Computer Systems Validation Prepare and Execute URS/FRS, Design Specification , Installation Qualification (IQ), Operational Qualification, Performance Qualification (PQ), Validation Summary Report (VSR) Experience and knowledge of 21 CFR Part 11, GAMP 5 guidelines especially in the areas of quality critical computer systems application.

executive - corp quality it

sun pharma

2015-10 - Present · 11 yrs

engineering officer

amneal pharmaceuticals

2015-4 - 2015-9 · 6 mos

Responsible for qualification and validation documents of engineering, SOP preparation of Computer based system (PLC, SCADA, etc..), Preventive maintenance supervision, Department Training coordinator...

validation engineer

kevin technologies

2013-3 - 2015-3 · 2 yrs 1 mo

* Experience in overall Life cycle of Computer Systems Validation * Prepare and Execute URS/FRS, Design Specification , Installation Qualification (IQ), Operational Qualification, Performance Qualification (PQ), Validation Summary Report (VSR) * Experience and knowledge of 21 CFR Part 11, GAMP 5 guidelines especially in the areas of quality critical computer systems application.