TTA - Pharmaceutical Quality Assurance Manager
2 weeks ago
Before you start, please review the Temporary Transfer Assignment Guidelines on RescueNet to make sure you qualify to applyTitle: TTA - Pharmaceutical Quality Assurance ManagerSector: Global Supply ChainLocation: RemoteStart Date: December 01, 2024Duration: 6 MonthsScope of work & objectives: APPLICANTSTo apply to this TTA, please email updated CV to Hamza.Sarieddine@rescue.org and subject the email as "TTA - Pharmaceutical Quality Assurance Manager". This opportunity is intended for internal IRC staff only.Overview The Pharmaceutical Quality Assurance Manager supports the IRC's pharmaceutical quality assurance function globally. The scope includes all Pharmaceutical products, Medical Devices & Equipment, Nutritional products, personal protective equipment, Laboratory equipment and supplies, IPC material and other health-focused categories which IRC procures, inventories, distributes and uses. The role facilitates alignment of global and national Health Programs and Supply Chain groups, and supervises Health Program quality assurance, GDP, and pharmacovigilance processes, procedures, and requirements.Key Objectives & Scope of Work Interface with GSC Pharma QA for the communication of IRC global quality assurance policies and procedures and Quality Management Systems (QMS) across the IRC Health Supply Chain in the supported CPs.Lead on the implementation and embedding of the Pharma databases: Work with CP Pharmacists to update lists of prequalified suppliers (IRC + QUAMED) + consolidate locally reviewed sourced (validated Quality Comparison Tables) and complete the CP Pharma databases (update all existing CP Pharma Databases + draft new databases for the remaining CPs). All CPs should have an up-to-date Pharma Database by end of Q3 FY25. Lead on training the CP Pharmacists on updating the databases (new products entry/supplier PQ tracking)Co-lead on drafting and completing a Global Pharma Database (consolidation of all CP Pharma databases in a global tracker)Lead on building a central online folder - to organize all the pharma QA system reports & records (complaints, recalls, reports on expired and damaged inventories, incidents at reception e.g. cold chain breaches, donations, DMC reports, RFPs and others)Ensure that all staff have access to Good Distribution Practices (GDP) and QMS training - Prepare training plans and lead on delivering GSDP trainings to all relevant national staff as required.Support in managing Country Program quality assurance, supplier and product quality investigations, and appropriate escalation of quality issues.Co-lead on IRC supplier prequalification program in the supported CPs, which includes facilitating reviews of suppliers site GDP assessments + GMP products sources verification.Support and enable IRC pharmaceutical distribution centres in GDP site and equipment qualification, self-inspection, and corrective action plans: Support GSC Pharma QA Snr. Manager with the global GDP data analysis and follow up on CAPA plans from the FY23 assessments + support with the planning/initiating of new GDP assessments for FY25 in Q3 (May/June).Participate in bimonthly Pharma meetings with GSC Pharma QA, Pharma TA and CP Pharmacists. And support with the onboarding of new pharmacists and SCCs (Pharma induction)Replace the GSC Pharma QA Snr Manager when out of office.Deliverables: Completion of all CP Pharma databases Trainings all CP Pharmacists on the use/update of the CP Pharma databases Building the online folder for QMS recordsGlobal Pharma Database draftKey Working Relationships The TTA Pharma QA Manager Reports to: GSC Pharmaceutical Quality Assurance Senior Manager. The TTA Pharma QA Manager will work with: Global Level:HSC working group:GSC Pharma Procurement + HU Pharma TAs Regional Level: RSCD & RSCC / AMU: Program & Awards Advisors / R&C Country level: CP Pharmacists / SCC External: Suppliers / QUAMED / HULOSupported CPs Asia: Afghanistan, Pakistan, Bangladesh, Myanmar, Thailand MENA: Syria (NES & NWS), Lebanon, Jordan, Libya, Yemen WA: Nigeria, Mali, Burkina Faso, Sierra Leon, Niger, Cote D'Ivoire, Liberia CA: DRC, Chad, CAR, Tanzania EA: Kenya, Somalia, Uganda, Sudan, South Sudan, Ethiopia LatAm: Colombia, Venezuela, Peru, Ecuador, El Salvador, Mexico EHAU: Ukraine, Haiti, oPtAssignment Duration It is expected that the TTA will take no longer than six months starting from Dec 2024 until May 2025.Requirements:Pharmacist with strong experience in Pharmaceutical Quality Assurance Systems and Health Supply Chain Management - Good Knowledge of the WHO MQAS, Good Distribution Practices and Good Manufacturing Practices.Have the required capacity and expertise to provide technical support for assessment and strengthening of health commodities and supply chain management systems.Proven experience of leading on local suppliers' prequalification GDP technical visits, and is familiar with the IRC's updated Prequalification process and Database template. Previous participation in QUAMED or similar audits is an asset.Good collaborator with excellent analytical skills. Strong attention to detail, organizational, and time management skills. Able to handle multiple tasks simultaneously in a fast-paced environment, set priorities, and meet deadlines.Strong organizational performance skills, refers to the ability to interact effectively with international and national staff.Self-directed, with a strong sense of personal integrity and understanding of confidentiality and ethics.Proficient in Microsoft Office, particularly Excel.Fluent in spoken and written ENGLISH. FRENCH is an asset.EligibilityWorking for the IRC for a minimum of one year.Received at least a "successfully meets expectations" rating (or equivalent) on their last annual perfor
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