Plans and coordinates activities to ensure regulatory lifecycle management activities and approvals are achieved by the Local Operating Company in a timely manner for all globally approved products.
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.
Oversees the development, implementation, and maintenance of the Quality Management System within the Probiotics or Non-Aseptic manufacturing facility. This includes ensuring that all processes, procedures, and documentation comply with relevant regulatory standards such as Good Manufacturing Practices.
B.Pharm, M.Sc, M.Pharm with 3-8 years of experience in IPQA and manufacturing, packing QMS related activities in oral solid dosage form tablets, capsules, soft gelatin capsules, pellet Dosage form manufacturing facilities.
Can handle instrument i.e HPLC- Dissolution 3C, IR,UV, QC QMS, Material testing xposure on EM, water testing, MLT testing of FP and RM/Stability samples , Analysis and review of Micro samples, reports.
Having Injectable Experience of Shop floor Supervising activities like Aseptic Filling, Autoclave Operations, Compounding vessels operations, Manpower Planning, Change Controls, investigations, CAPA, Vial Washing, Lyophilizers and Training and QMS
Endo India Par Formulations is a pharmaceutical company that develops, manufacturers and markets safe, innovative and cost-effective pharmaceuticals that help improve patient quality of life. At Endo our investment in state-of-the-art equipment and facilities, commitment to ethical standards, and growing portfolio of products makes us a company where you can enjoy a productive career with long-term potential.
M.Pharm, Pharm.D, BDS Postgraduate in registered life Sciences. Min 2 - 4 years relevant experience into Pharmacovigilance case processing and related activities in alignment with patient safety operations.
Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management. Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities