Conduct medical review of all trial subjects in assigned clinical trials to ensure high-quality, consistent medical data. Ensure patient safety and adherence to protocols, Good Clinical Practice, ICH Guidelines, local regulations, and SOPs.
Diploma/ BPharmacy/ MSc/MPharmacy work in in QA, Production at Aspiro Pharma. Having Injectable Experience of Shop floor supervising activities like Filtration, Filling, Sealing, Stoppering, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes. Operations and Training and QMS.
This role is responsible for providing support to the global regulatory and pharmacovigilance departments regarding regulatory and pharmacovigilance information of the legacy products and sites.
Manage regulatory audits, customer inspections, and internal audits; ensure effective handling of OOS/OOT, deviations, CAPA, and change control activities.