• Provides technical assistance in terms of adhering to regulatory affairs in Pakistan that will enhance the ability of USP PQM to conduct its technical assistance work to improve medicine quality assurance program in Pakistan, with specific work requested by program partners and approved by PQM.
• Works hand-in-hand with the Technical Manager, to provides technical advice to selected manufacturers, particularly in Good Manufacturing Practice (GMP), medicines regulation and pharmaceutical product assessment through the PQM program.
• Maintains partnerships and coordination to ensure continuity of external technical advice and support, both within PQM, including establishing a forum of experts and on-going activities by major regulatory agences in Pakistan.
• Provides technical assistance to DRAP on therapeutic product Common Technical Document (CTD) dossier evaluation and any related regulatory requirements.
• Conducts need assessment, framing QMS framework and development of institutional developmental plans for all regulatory functions.
• Provides technical assistance to provincial drug control administrations on all regulatory aspects.
• Manages specific PQM project activities as assigned by the PQM Chief of Party and/or the PQM HQ, Pakistan.
• Ensures that all project work for the PQM office is completed by country partners on time, on target and on budget.
• Participates in the development of new USAID projects and activities and obtains approval of PQM, Rockville-USP.
• Provides assistance in the formulation of medicines regulation guidelines to improve quality and safety of medicines in line with the national regulatory system.• Actively take part in preparing quarterly and annual activity reports to USP-PQM, USAID Pakistan, and other country partners within the set parameters of the contract.
• Participates as appropriate in technical meetings, conferences and workshops organized by country partners on behalf of USP-PQM Pakistan and makes presentations on PQM activities in Pakistan when required.
pThe U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Our mission is to improve global health throug ...Read More