Batch release and associated documents - preparation and review. Understanding of QMS elements and IPQA. Internal and external Regulatory team coordination.
Expertise in Virus Propagation, Cell-Culture, Protein Purification, Immuno-analytical Methods, Microbial Fermentation, Molecular Biology. Experience in human vaccines development is a plus.
PhD, M.Sc, M. Tech Biochemistry, Biotechnology, Life sciences with 2 - 8 years hands-on experience in protein purification techniques like centrifugation, depth filtration, lab scale column purification, ultrafiltration, diafiltration.
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. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.
Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting.
Prepare and compile DMFs in compliance with regulations for regulatory and semi-regulatory countries. Provide necessary documentation support to the Marketing department.
We have a specialized R&D facility in Chennai as well as top-notch manufacturing operations in India. In Chennai, there is a specialized OSD research and FRD at Chennai