Prepares periodic safety update reports in compliance with drug safety regulations and ICH Guideline. Utilizes best medical judgement in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other impreciseness in reporting by actively liaising with the reporting sites.
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
Discuss base forecast and bottom up forecasts with sales & marketing team and develop consensus forecast. Upload consensus forecast in system and share with Supply Planning Team
Demonstrates a robust scientific approach to laboratory analysis. Regularly utilizes personal experience, academic training, and technical insights, including emerging sciences, to address complex technical issues within the laboratory.
Influences and inspires own team and/or brings matrix collaborators together across the organization with eye for progressing teams towards decision points and deepening scientific understanding.
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.
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.
Exposure of handling and compliance of various compression, coating and granulation machines, equipment Online documentation of BMR and log books during execution of batches.