Regulatory Pharmacist

4 weeks ago

Cape Town, South Africa Médecins Sans Frontierès Full time

SUMMARY OF THE POSITION

Doctors without Borders seeks to employ a suitable Regulatory Pharmacist to join the Southern Africa Supply Office (SASU). The Regulatory Pharmacist will define, coordinate, and monitor 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 specialised food).
This will be done according to MSF standards and values, the Network Manager’s instructions, and the OCB GSDP Guidelines, with consideration and compliance to national and international pharmaceutical laws and regulations, to ensure the quality and proper organization of the medical supply process, procedures and protocols, and all purchases for import/export to MSF Missions. Responsible for ensuring compliance with the quality assurance medical procurement policy.
OVERALL RESPONSIBILITIES
1. 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 procedures (SOPs, templates, checklists, etc.) to ensure adherence to the GSDP for SASU activities.
- Create and manage the SASU Medical Products Database.
- Support MSF Pharma in the qualification of medical products and validation of pharma manufacturers, wholesalers and distributors in South Africa

2. Tasks and Responsibilities
Regulatory:

- Advise the CST, RST, and HQ Pharma Teams on the pharmaceutical legislation in South Africa concerning pharmaceutical activities performed by SASU and the MSF South African Projects and ensure updates/amendments are communicated internally.
- Ensure all SASU pharma activities are GSDP compliant and meet the MSF Medical Procurement Policy requirements and the South African Pharmaceutical Legislation.
- Supporting the Network Manager, Regional Pharmacist and Regional Strategic Medical Representative in representing and defending MSF’s 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 DOH or any other authority regarding any challenges relating 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.
- Collect data from local pharma manufacturers and distributors for database management.
- Develop relationships with local pharmaceutical manufacturers/distributors, responsible pharmacists, and regulatory affairs departments, and obtain any information the QA pharmaceutical teams require to qualify medical products and validate suppliers.
- Support the Regional Pharmacist in 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 the guidelines on Good Wholesaling Practice (GWP) / Good Distribution Practices (GDP) are met.
- Develop, monitor and update SASUQMS documents, including Standard Operating Procedures (SOPs) related to medical
procurement, in cooperation with the SASU Network Manager, the Regional Pharmacist and the OCB Responsible Pharmacist, and ensure compliance with the sops.
- Ensure that SASU personnel involved in managing the Medical Product are initially and continuously trained on GSDP and that their responsibilities concerning GSDP are clearly mentioned in the job descriptions.
- Ensure that SASU observes good storage and distribution practices, as WHO, national legislation, and MSF guidelines recommend.
- Ensure the respect of the MSF medical procurement policy regarding both SASU regional 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.
- Give support in the SASU ordering and supply process of Medical Products.
- Ensure that medical products are imported and exported according to the respective country's pharmaceutical legislation, with the collaboration of the relevant MSF regional transport and customs focal points and supply departments and 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 cold chain products are handled according to MSF OCB standards and regularly contact 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 upon, 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 meetings to the Network Manager
and 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 organization.
- Salary package comparable to other non-profit organizations.
- 100% health insurance coverage.
- 10% pension contribution towards the employer fund.

TO APPLY: Please email a one-page motivation letter and your comprehensive CV with details of three contactable referees to Msfocb-southafrica-admin@brussels.msf.org
Doctors Without Borders South Africa Mission NPC reserves the right not to make an appointment if a suitable candidate cannot be
found. While we thank all interested applicants, further communication will only be limited to short-listed candidates.

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