Personal Information
Organization / Workplace
Pune Area, India India
Occupation
Sr. Manager QC at Serum Institute of India Limited
Industry
Medical / Health Care / Pharmaceuticals
About
Currently leading the team of Quality Control Unit and Analytical Development Laboratory (ADL).
Successfully established an independent QC laboratory for Pharmaceutical / Anticancer operations at SIIL to meet global standards.
Handled analytical method development, validation, routine analysis, material management, stability study, training, certification of analyst, calibration, OOS/OOC/OOT investigations, Change controls, deviations, setting specifications, development studies, etc.
Handled audits of regulatory authorities of different countries including USFDA, MHRA, TGA, MCA, ANVISA, WHO, PIC'S, Etc.
Established a Quality Control System meeting the 21CFR Part 11 requirements.
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