Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
Bachelor degree in a relevant field, such as Life Sciences or Healthcare. Proven experience in clinical data management within the pharmaceutical or biotechnology industry. ICON plc
Supervise and execute manufacturing activities in Granulation, Coating, Compression, and Capsulation as per cGMP and approved SOPs; Operate and monitor manufacturing equipment, ensuring proper batch setting, material handling, cleaning, and equipment performance, Amneal Pharmaceuticals
Lead ISI Mark and CRS certification projects from application to grant. Prepare and review all documentation for BIS portal submissions. Coordinate product testing with BIS-recognized laboratories
Develop, maintain, and update laboratory systems and documentation, including SOPs, IQ/OQ/PQ documents, training records, and related quality documents.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world.
Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles