looking for an expert in Formulation development of Oral Solid & liquid dosage forms of regulatory markets. To coordinate with various CROs and internal Formulation R&D and Formulation Analytical R&D on the technical aspects of product development activities from development to filing stage.
Demonstrate expertise in tablet and capsule manufacturing processes, including granulation, compression, coating, and filling. Operate production equipment such as MG, FBD, compression machines, coaters, and capsule filling machines.
Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. Leads the safety component of global regulatory submissions.
Torrent Pharma, the flagship Company of Torrent Group is one of the leading pharma companies of the Country. The Company was a pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.
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.
The purpose of the Quality Medical Reviewer role in Medical Affairs is to review and approve medical and promotional materials to ensure they are medically accurate and interpreted correctly based on the review of references, citations and data available.
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.