Promptly notify and escalate to JAMP headquarters quality department any potential quality or regulatory issues that may affect product quality or regulatory compliance
Unique Pharmaceuticals Limited is a pioneer in the pharmaceutical industry in Nigeria. We have been serving the healthcare sector since 1988 through the production & distribution of quality pharmaceutical products, notably I.V. Fluids products manufactured using the innovative and High -Tech manufacturing process known as Form – Fill – Seal Technology.
Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets. Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies
Must have experience in the development of nasal spray, nebuliser and other respiratory dosage form. Exposure of regulated and domestic product development
Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia
Exposure in investigation of UPD , OOS, OOT, EM and Change control & CAPA Management. Preferable for exposure in Regulator}’ and FDA Audits, Knowledge and exposure for aseptic operations and principal of its relevant equipment.
2-7 years of experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic and control area operation, documentation, both SVP and LVP manufacturing etc.
B. Pharm, M. Pharm, B.Tech. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.