M.Pharm, B.Pharm, M.Sc, B.Sc; Responsible for accurate production and packaging changeovers as per packaging schedule. Maintain a clean work area and clean equipment before and after shift.
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
Planning and execution of batch packing activities such as Dispensing & Line clearance. Expertise in handling Blister, Bottle and Sachet packing machineries like BQS, CAM, Maspack, Auto Cartonator etc.
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
Co-ordination with product development team to keep track of various projects. Sample seeding from suppliers for project initiation. Co-ordination with supplier, principle for arranging quality documents.
Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable
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.