Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.
Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Water and Bioburden Testing and Microbiological limit testing, Sterility Testing and BET Testing, IQ,OQ and PQ of equipment, Trend Analysis preparation, Biological reactivity test, EM Observation - Moda exposure
Experience must include analysis of Raw Material, In-Process, finished goods; Stability Testing & Stability sample handling for Tablets, Capsules Handling of HPLC, dissolution & other sophisticated instruments.