Regulatory Pharmacist: SASU

SUMMARY OF THE POSITION

Doctors without Borders seeks to employ a suitable Regulatory Pharmacist to join the Southern Africa Supply Office (SASU).

The Role of the Regulatory Pharmacist will be defining, coordinating and monitoring all pharmacy-related activities performed by the Southern Africa Supply Unit (SASU) based in South Africa for Medical Products (medicines, medical devices, in vitro diagnostics, laboratory items, Medical consumables and specialized food, etc.). This will be done according to MSF standards and values, the Network Manager’s instructions, and the OCB GSDP Guidelines and with consideration and compliance to the national and international pharmaceutical laws and Regulations, in order to ensure the quality and proper organization of the medical-supply process, procedures and protocols, and all purchases import/export to MSF Missions.

Responsible for ensuring compliance with the quality assurance medical procurement policy.

OVERALL RESPONSIBILITIES

Objectives of the Position

• Regulatory focal point for the importation/exportation, acquisition, storage and distribution of Medical Products procured in South Africa on behalf of SASU for MSF Missions.
• Develop and monitor the SASU Quality Management System and related set of procedures (SOPs, templates, checklists, etc.), to ensure adherence to GSDP for SASU activities.
• Create and manage the SASU Medical products base.
• Support MSF Pharma in the qualification of medical products and validation of pharma manufacturers, wholesalers, and distributors in South Africa.

Tasks and Responsibilities

Regulatory:

• Advise the CST, RST, and HQ Pharma Teams on the pharmaceutical legislation in South Africa as it pertains to pharmaceutical activities performed by SASU and the MSF South African Projects and ensure updates/amendments are internally communicated.
• Ensure all SASUpharma activities are GSDP compliant and meet the requirements of the MSF Medical Procurement Policy and the South African Pharmaceutical Legislation.
•  Supporting the Network Manager, Regional Pharmacist and Regional Strategic Medical Representative in representing and defending interests before the Department of Health, the National Drug Regulatory Authority and other local authorities or local suppliers for any issue concerning pharmaceutical supply, to ensure stock procurement in the South African MSF projects.
• In collaboration with the Regional Pharmacist, follow up with the DOHC or any other authority regarding any challenges to
  Local MSF procurement and importation/exportation of Medical Products.

Quality Assurance:

• Create and maintain the SASU Medical Products Database, which includes medical products utilized in the Southern Africa MSF
  Missions.
• Collecting data from local pharma manufacturers and distributors for database management.
• Develop relationships with local pharma manufacturers/distributors, responsible pharmacists&regulatory affairs department,t and
  obtain any information required by the pharma teams for the qualification of medical products and validation of suppliers.
• Support the Regional Pharmacistin visits/audits to wholesalers, distributors and manufacturers and report on their GMP/GDP
  compliance.
• Audit third-party contractors on GSDP activities outsourced by approved wholesalers, distributors and manufacturers

Duties:

• As the MSF-appointed Authorized Representative for the SAHPRA wholesale license of medical devices & DVDs; to ensure that the
  conditions of the wholesale license have been and are being complied with, and that the guidelines on Good Wholesaling Practice
  (GWP)/ Good Distribution Practices (GDP) are met.
   
• Develop, monitor and update SASUQMS documents, including StandardOperating Procedures(SOPs)related to medical
  procurement, in cooperation with the  SASUNetwork Manager, the Regional Pharmacist and the Responsible Pharmacist; and
  ensure compliance to the SOP’s.
• Ensure that SASUpersonnel involved in the management of the Medical Product are initially and continuously trained on GSDP
  and that responsibilities concerning GSDP are clearly mentioned in the job descriptions.
• Ensure that SASU observes good storage and distribution practices in accordance with WHO guidelines, national legislation, and MSF’s guidelines.
• Ensure the respect of the MSFmedicalprocurement policy regarding SASUregional and local medical product purchases
• Refer to the Regional Pharmacist and OCB-Pharma-QA for approval of exceptional validation of SASU regional and local medical product purchases.
• Support the SASUordering and supply process of Medical Products.
• Ensure that the importation and exportation of medical products is done by the respective country's pharmaceutical legislation, with the collaboration of the relevant MSF regional transport & customs focal points and supply departments, as well as the European Supply Centers(MSF Log and MSF Supply).
• Be the focal point for handling and recording complaints, returns, quality alerts and recalls for Medical Products procured by
  SASU; according to written procedures based on WHO guidelines and national legislation.
• Ensure that the handling of cold chain products follows the MSFOCB standards by being regularly in touch with the OCB cold chain technical referent.
• Review and sign quality agreements with wholesalers, distributors and manufacturers.
• Ensure that any activity covered by GSDP guidelines that is outsourced to third parties is correctly defined, agreed and controlled to avoid misunderstandings that could affect the product's integrity. These services could include reception/inspection and release of medical Products, transport of temperature-sensitive pharmaceuticals, destruction of Medical Products, etc.

Representation and Oversight Roles

• Attend external meetings or conferences and communicate any relevant outcome of the meeting to the Network Manager
  and/or any other relevant party.

REQUIREMENTS:

• Essential: Pharmacy Degree (recognized in the country as per regulatory authorities requirements).
• Current and valid registration with the South African Pharmacy Council (SAPC).
• Two years of demonstrated experience as a Responsible Pharmacist or Qualified Person is required.
•  Experience in MSF or other NGOs in developing countries is desirable.
• Experience in designing and managing a Quality Management System is strongly desirable.

Job Advantages and Career Opportunities:

•  Experience in a well-known and professionally recognized international medical humanitarian organisation.
• Salary package comparable to other non-profit organizations
• 100% health insurance coverage.
• 10% pension contribution toward the employer fund.

TO APPLY: Please email a one-page motivation letter, your comprehensive CV with details of 3 contactable referees to:
msfocb-southafrica-hr@brussels.msf.org

Doctors Without Borders South Africa Mission NPC reserves the right notto make an appointmentif a suitable candidat