Mr. Budhish Singla has more than 18 years of industrial experience in manufacturing operations, scale-up and scale-down of vaccines and enzymes from recombinant strain in yeast fermentation and downstream processing. His extensive expertise encompasses predominantly chromatography process development including commissioning & validations.
He is well versed with Quality risk management, Establishment/implementation of QMS in existing and upcoming manufacturing units, Validations (Process, cleaning, system and equipment).
He has audit experience conducted by esteemed bodies such as CDSCO, WHO-Geneva, AMRH, and third-party auditors.
His expertise encompasses awareness of Good Manufacturing Practices (GMP) along with applicable regulations and guidelines, including those established by entities like WHO, and 21 CFR Part 211.
