The Quality Assurance Officer (QAO) supports the quality assurance component of the supply chain managed by GHSC-PSM Haiti. The QAO works under the supervision of the Senior Technical Advisor and Quality Assurance (STQAA) and in collaboration with other PSM units to ensure the quality and reliability of pharmaceutical products purchased and distributed by the project. The QAO will follow the implementation of appropriate quality management procedures for pharmaceuticals and report on compliance deficiencies associated with quality assurance. The QAO will audit the quality of all medicines and products purchased by PSM Haiti and maintain appropriate records of these audits to facilitate corrective actions. The QAO also keeps up to date pharmaceutical information related to HIV / AIDS and FP and help to ensure that the PSM project in Haiti take buying decisions based on the latest information on drug safety and availability as required by standards quality.
Fonctions
1. The QAO manages the documentation for the implementation of the QA system and product quality control and all required reports in accordance with the regulations of GHSC-PSM and USAID;
2. The QAO maintains temperature requirements in different storage places where PSM products are stored. He/she participated in the development of tools for monitoring temperature and humidity at the different storage areas (room, pharma grade, and cold room). It conducts regular mappings to ensure that temperatures do not exceed the tolerance limit. He/she analyzes the causes of the irregularities and written reports and proposes solutions to improve the process as a guide to the activities of CAPA;
3. The QAO records temperature conditions at Fleuriot warehouse and ensures that all PEPFAR sites are equipped with appropriate temperature recording instruments;
4. The QAO in collaboration with the warehousing and distribution units, monitor the cold chain process for the transport and distribution of products by 3PLs and makes recommendations to improve the reliability of the cold chain during the transport of goods and prevent the occurrence of incidents that may affect product quality. Furthermore, the QAO checks the cold chain equipment to ensure they meet WHO requirements for temperature and humidity control, and the necessary autonomy for the travel. He / she implements the temperature recording process during the transport and ensure that the recommendations are followed correctly and immediately by 3PLs;
5. The QAO investigates returned products that were out of the PSM control cold chain and storage conditions and ensure that these products are not returned to the main warehouse storage. He / she ensure that there is a clear process for returning products and its implementation is respected as recommended;
6. The QAO serves as a technical officer in charge of evaluating the quality of products for PSM in Haiti;
7. The QAO, in collaboration with the procurement team, advises on the remaining Shell-life of the products before shipping. He / she controls the certification of the quality of products before shipment to Haiti;
8. The QAO works in close collaboration with the team of the warehouse, to audit and sample the products received in the warehouse before their distributions. He / she performs random or regular quality checks on the products supplied; he / she analyzes the reasons of poor quality of the products to minimize the impact of problems;
9. The QAO assists in the analysis and response to the issues raised by the sites about the quality of medicines distributed by PSM. He / she develops a database or holds a register of adverse drug reactions, labeling changes, security alerts, and reminders. He / she supports the drug recall process and the QA roles in identifying and responding to complaints (product quality) and to customer needs;
10. The QAO, in close collaboration with warehousing and distribution units and with other technical units, and the partners’ networks logistics advisors (PNLAs) supports the development of data collection tools for quality assurance in all operations of receiving, storage, and distribution of PEPFAR products (at central and sites levels);
11. The QAO supports the risk management component of the QA system for PSM Haiti;
12. The QAO maintains daily tasks to ensure that the Haiti GHSC-PSM employees follow standard QA. He / she identifies the training needs of staff and partners supports the development of specific modules that will address the needs identified.
13. The QAO helps building and strengthening the standards of quality assurance capacity and nationally certified SOPs for control of PEPFAR products in the supply chain in the country
Other: The Quality Assurance officer performs other tasks assigned by the supervisor that are consistent with their skills and experience
Qualifications Requises
? Pharmacy degree and / or master's degree (or above) in QA or in related fields;
? At least five years of proven experience in pharmaceutical management;
? Proven knowledge of pharmaceuticals and laboratory commodities and on the treatment and management of HIV / AIDS and Family Planning;
? Demonstrate knowledge of running quality assurance procedures and implementation of supply chain programs;
? Experience in the health sector, particularly the Haitian health system;
? Ability to communicate effectively, orally and in writing in French, English; can speak Haitian Creole
? Proven ability to maintain effective working relationships with health workers, procurement managers, foreign or American organizations and the private sector.
Conditions particulières
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