Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.
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.
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
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.
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.
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
Gufic Group have been in the Pharmaceutical industry since 1970 and are known and respected for Innovative and high Quality pharmaceutical and Herbal Products along with a wide range of APIs Gufic