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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES
SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.
QMS OFFICER
SALARY: R778 447.00 – R826 197.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 35/2025
(CONTRACT POSITION UNTIL 31 DECEMBER 2026, WITH POSSIBLE EXTENSION BASED ON PERFORMANCE)
CENTRE: Pretoria
REQUIREMENTS: ● Applicants must have a Matric certificate and an appropriate three-year National Diploma at NQF Level 6 as recognised by the South African Qualifications Authority (SAQA) in Life/Natural Sciences/Quality Management or Technical Related. Certificate in ISO 9001, including lead auditor certificate. A valid driver’s licence is required. A South African Auditor and Training Certification Authority registration will be an added advantage
EXPERIENCE: ● Minimum of three (3) years post qualification experience in Quality Assurance within healthcare, regulatory environment, Pharmaceutical and/or Medical Devices sector. Knowledge of Regulatory requirements. Experience in implementation and maintenance of Quality Management System. Knowledge of ISO 17025 will be an added advantage.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Excellent interpersonal and communication skills (written & verbal), *Knowledge of ISO 9001 standard and expertise in quality management systems, *Computer literacy with MS Office, *Sound knowledge of process plotting/mapping, *Critical thinking and the ability to exercise good judgment and solve problems quickly and effectively, *Accuracy and attention to detail, *Planning and organisational skills, *Time management skills, *Client orientation and customer focused, *Proactive stakeholder management, *Knowledge management.
DUTIES: ● Implementation and maintenance of the Quality Management System (QMS): *Assist the QMS Manager with the maintenance of quality management system, *Ensure maintenance of ISO 9001 Certification, *Ensure that the implemented system is measured, monitored, and maintained for continuity, *Ensure QMS governance and operational documented information.
● Document and Records Management: *Ensure documents are properly reviewed, approved, and updated, *Ensure accessibility, version control, and archival of regulatory documents.
● Compliance and auditing: *Conduct QMS Internal audits, *Perform routine spot checks to ensure adherence to documented procedures, *Identify deviations from established procedures and initiate corrective/preventive actions, *Ensure that all corrective and preventive actions are effectively implemented and documented, *Monitor compliance with procedures and timelines, *Accurate inputs to management review, *Maintenance of related records, *Conduct QMS Awareness/Training, *Ensure QMS activities align with best practices for quality assurance, *Report on the performance of the quality management system and recommend enhancements.
● Training and Support: *Training SAHPRA staff on QMS requirements and quality awareness, *Provide guidance to Programmes and Units on quality-related processes, *Provide guidance to SAHPRA staff to ensure adherence to quality policies and procedures.
QMS OFFICER
SALARY: R778 447.00 – R826 197.00 PER ANNUM (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 35/2025
(CONTRACT POSITION UNTIL 31 DECEMBER 2026, WITH POSSIBLE EXTENSION BASED ON PERFORMANCE)
CENTRE: Pretoria
REQUIREMENTS: ● Applicants must have a Matric certificate and an appropriate three-year National Diploma at NQF Level 6 as recognised by the South African Qualifications Authority (SAQA) in Life/Natural Sciences/Quality Management or Technical Related. Certificate in ISO 9001, including lead auditor certificate. A valid driver’s licence is required. A South African Auditor and Training Certification Authority registration will be an added advantage
EXPERIENCE: ● Minimum of three (3) years post qualification experience in Quality Assurance within healthcare, regulatory environment, Pharmaceutical and/or Medical Devices sector. Knowledge of Regulatory requirements. Experience in implementation and maintenance of Quality Management System. Knowledge of ISO 17025 will be an added advantage.
COMPETENCIES, KNOWLEDGE AND SKILLS: *Excellent interpersonal and communication skills (written & verbal), *Knowledge of ISO 9001 standard and expertise in quality management systems, *Computer literacy with MS Office, *Sound knowledge of process plotting/mapping, *Critical thinking and the ability to exercise good judgment and solve problems quickly and effectively, *Accuracy and attention to detail, *Planning and organisational skills, *Time management skills, *Client orientation and customer focused, *Proactive stakeholder management, *Knowledge management.
DUTIES: ● Implementation and maintenance of the Quality Management System (QMS): *Assist the QMS Manager with the maintenance of quality management system, *Ensure maintenance of ISO 9001 Certification, *Ensure that the implemented system is measured, monitored, and maintained for continuity, *Ensure QMS governance and operational documented information.
● Document and Records Management: *Ensure documents are properly reviewed, approved, and updated, *Ensure accessibility, version control, and archival of regulatory documents.
● Compliance and auditing: *Conduct QMS Internal audits, *Perform routine spot checks to ensure adherence to documented procedures, *Identify deviations from established procedures and initiate corrective/preventive actions, *Ensure that all corrective and preventive actions are effectively implemented and documented, *Monitor compliance with procedures and timelines, *Accurate inputs to management review, *Maintenance of related records, *Conduct QMS Awareness/Training, *Ensure QMS activities align with best practices for quality assurance, *Report on the performance of the quality management system and recommend enhancements.
● Training and Support: *Training SAHPRA staff on QMS requirements and quality awareness, *Provide guidance to Programmes and Units on quality-related processes, *Provide guidance to SAHPRA staff to ensure adherence to quality policies and procedures.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY):
- Interested persons who meet the above-stated requirements should submit their application, clearly state the position name and post reference number, including a signed cover letter, clearly state the position name and post reference number, detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, copies of required qualifications (including matric). ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview, following communication from Human Resources.
- Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA.
- Incomplete applications or applications without the aforementioned documents or information will not be considered.
- No late applications will be accepted. Any submissions received after the specified date and time will not be considered, and CVs will not be returned.
- Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful.
- Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA.
- Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience.
- SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. Applicants with disabilities are encouraged to apply and indicate their disability status, which will be appreciated.
- SAHPRA reserves the right not to make any appointment(s) to the advertised post(s).
- SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes.
- Applications should be submitted through the SAHPRA Website Online Portal: https://www.sahpra.org.za/vacancies.
- For enquiries: Please contact Mr T Khunou, HR Business Partner, via email at Tshepo.Khunou@sahpra.org.za. NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS.
The closing date is 22 August 2025 at 16:00.