SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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INSPECTOR GCP x2 
(FIXED TERM CONTRACT: ENDING 31 MARCH 2025) 
Salary: R788 910.00 – R837 326.00 p/a (All-inclusive) 
Ref No.: SAHPRA 015/2022 
CENTRE: Pretoria 
 
REQUIREMENTS:
• Four 4-year Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Medicine, Veterinary, Biological Sciences, Biomedical Science or relevant fields. 
a. Proof of current registration (Recent Designation Letter) as a pharmacist must accompany your application if you have a B-Pharm degree). 
• Minimum of five years’ experience in clinical trials and bio-equivalence studies. 
• Extensive knowledge of GxP regulations and industry practices, as well as substantial experience of undertaking GxP inspections within the regulatory environment. 
• Sound knowledge of Medicine and Related substances Act 101 of 1965 as amended and all regulations pertaining to the Act. 
• Every Inspector shall be furnished with a certificate signed by Director-General and stating that they have been authorised as an inspector under this Act. 
 
KNOWLEDGE AND SKILLS: * Comprehensive and Sound knowledge of all relevant legislation, regulations and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. Good communication skills (verbal, written, conflict management and resolution). Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expect decisions and advice while carefully considering the implications of such a decision. Ability to work unsupervised for long periods of time. *Ability to work within a team environment. *Good planning and organisational skills. *Ability to meet tight deadlines and manage multiple, often competing priorities. *Knowledge of MS Office. *Valid driver’s license. *Ethical behaviour and adherence to the SAHPRA Code of Conduct.
 
DUTIES:
• Inspect clinical trial vendors, laboratories, and other identified sites for compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) as accepted by SAHPRA. 
• Assess and evaluate GCP inspection reports of other regulatory authorities on international bioequivalent trials to verify clinical data to support registration of medicines in South Africa. 
• Work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively.… 
• Evaluate Standard Operating Procedure (SOPs) of Inspectorate for compliance with GCP Guidelines as adopted by SAHPRA. 
• To contribute to the inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in the appropriate manner. 
• To prepare reports for SAHPRA and relevant advisory committees and the Finance department. 
• Liaise with inspectors from international regulatory authorities. 
• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate. 
• Interview members from the industry to discuss requirements of the Medicine and Related Substances Act, No. 101 of 1965. 
• To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentation all while demonstrating sound industry and technical knowledge. 
• Record statistics of generated and peer-reviewed reports. 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable. 
• Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA). 
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications. 
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered. 
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful. 
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA. 
 
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. 
 
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s. 
 
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 10 May 2023 at 16H00.
 
 
 
 

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MEDICINES REGISTRATION OFFICER – LICENSING: MEDICAL DEVICES 
Ref No.: SAHPRA 018/2023 
SALARY LEVEL 10: (R623 105 - R661 345) 
CENTRE: Pretoria 
 
REQUIREMENTS:
• An appropriate 4-year Pharmacy Degree or equivalent NQF level 7 or Life Sciences, relevant post graduate qualification maybe beneficial. 
• At least two (2) years’ regulatory experience in Medical Devices including IVDs
• An understanding of Medical Devices Vigilances requirements 
 
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES: *Sound knowledge of regulatory scientific and technical requirement of Medical Devices (including IVDs); *knowledge of quality, safety and efficacy aspects of Medical Devices (including IVD’s); *an understanding of the Medical Devices Establishment licensing requirements, Pre- and Post- Marketing Surveillance processes; *Preparation and management of operational and tactical plans, and budgeting; *Computer literacy and MS Windows computer skills, Excel and database applications; *Good report writing and presentation skills; *Good planning and organising skills; *Good verbal and written communication skills; * Self-motivated and able to work independently; Ability to manage a variety of cross-functional team members; *Pay attention to details and Information evaluated. 
 
DUTIES:
• Develop and maintain guidelines and standard operating procedure for medical devices and IVD registration; 
• Evaluate and manage licence applications for medical devices establishments and maintain relevant database; 
• Evaluate and manage applications for registration of medical devices and IVD’s and maintain relevant database; 
• Prepare reports for SHAPRA and relevant advisory committees; 
• Liaise with international regulatory authorities;
• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit; 
• Interview members of the industry to discuss SAHPRA Board resolutions, requirements of the Act and medical devices and IVD quality issues; 
• Investigate and attend to industry / applicants queries; 
• Perform other functions that may arise from time to time; 
• Capture and maintain data relating to measuring and monitoring of performance metrics and peer reviewed reports, and record statistics generated; 
• Manage the associated risks and audit queries, and correspondence from applicants and stakeholders; 
• Submit weekly work-plan and output to the Unit manager (quantitative and qualitative reports). 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s. 
• Applications without the aforementioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA). 
• A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications. 
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, will not be considered. 
• Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful. 
• It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA. 
 
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. 
 
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s. 
 
Enquiries: Email: Matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 05 May 2023 at 16H00.