Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
M.Pharm with 15 to 20 years of experience in Formulation development of sterile, non-sterile Dosage forms as per guidelines of US, EU, Canada, Brazil and ROW market. Literature search, Pre - formulation and compatibility studies,formulation & development as per QbD, Scale-up and Technology transfer.
Craft and maintain BPCRs and SOPs with precision, Lead documentation management using EDMS to uphold data integrity and compliance, Drive training and compliance efforts through our LMS, Ensure all production documentation aligns with regulatory standards and internal policies.
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management
After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.
Production QMS Quality Management System Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.
A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.