bhupendra gautam

I am post graduate in Pharmaceutics.

Competent in granulation, blending, compression, coating, capsule filling and liquid manufacturing area, handling SCADA & HMI based equipment HSMG/ FBD/ FBP/ compression machine (Fette, HATTA, Cadmac, Parle Elizabeth)/ Autocoater (ACG & Bectochem) with sound knowledge of troubleshooting.
Having good experience in production QMS activities, investigation of deviation, change control, CAPA, Risk assessment, etc.
Team member of projects for system up-gradation like data backups, E-logbooks, SCADA implementation
Expertise in qualification activities (Facility and Equipment) and process validation.
Performed gap analysis in system, process, SOP’s and in-line the system with respect cGMP.
Understanding of  21 CFR 11, 210, 211, GAMP 5, EUDRALEX and ICH guidelines; rich knowledge of cGMP concept defined by schedule M, WHO, MHRA and USFDA.
Proficient at supervising production work & documentation as per pharmaceutical industry regulations & various other regulatory authorities
Expertise in improving cost effective, safe & environment-friendly processes in manufacturing of products.
Audits faced, USFDA, MHRA, WHO, FDA, UGANDA, ETHIOPIA
Excellent operational/analytical, troubleshooting and interpersonal skills with proven capability in driving numerous quality enhancement, process improvement and cost saving initiatives during the carrier span
Devised batch manufacturing process including scale ups, cost improvements, validations, process optimization & control.
Acted as registered FDA “Technical person for Tablets and Capsule”

Master in Pharmaceutics