vinayak bommu

executive

About

Expertize in implementation of Commissioning, Qualification, Validation in pharmaceutical and biopharma organizations. Effective handling of Commissioning, Qualification and Validation related activities (HVAC & Equipment related). Experienced with Sterile pharmaceutical dotage forms like large & small volume parenterals and Vaccine production. Experienced in New Facility (INFUSION BAG FILLING LINE) Commissioning and Qualifications activities in Gland Pharma Limited.

Country

india

City

hyderābād

Industry

biotechnology

Skill

validation, gmp, pharmaceutical industry, standard operating procedure, pharmaceutics, quality assurance, cleaning validation, equipment qualification, validation master plans, qualification testing

Experience

qa

gland pharma limited

2013-7 - 2016-1 · 2 yrs 7 mos

*  Executing the equipments qualifications like performance qualifications and re qualifications. *  Preparation of validation protocols. *  Overseeing the compilation of validation protocols, reports and summary. *  Any other assignment allocated by Quality Assurance Manager.

executive

aurobindo pharma

2016-1 - Present · 10 yrs 9 mos

*  Review of SLIA, URS, DQ, IQ, OQ, PQ of equipments & Preparation of validation protocols. *  Execution of equipments like Autoclaves, Tunnels, Storage chambers qualifications. (performance qualifications and re qualifications). *  Data compilation of validation protocols, reports and summary. *  Review of activities as per Master revalidation and calibration schedule *  Any other assignment allocated by Quality Assurance Manager.