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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, 1965, (Act No. 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.
INSPECTOR: GMP
Ref No.: SAHPRA 052/2023
SALARY LEVEL: 11(R788 910 to R837 326 per annum Total Cost To Company)
CENTRE: Pretoria
REQUIREMENTS:
• 4-year bachelor’s degree in pharmacy, a. Proof of registration as a Pharmacist must accompany your application if you have a B-Pharm degree
• Minimum of 5 years’ experience in the Pharmaceutical industry or GMP environment
• Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment
• Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Comprehensive and sound knowledge of all relevant legislation, protocols, 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). * Resilience. * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert 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 pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA
• Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured
• Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier
• Perform Once-Off evaluation on information submitted by HCR (Applicants)
• To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively
• Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP 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
• 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 SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues
• To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge
• Record statistics of generated and peer-reviewed reports
• Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes
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 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 October 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 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.
INSPECTOR: GMP
Ref No.: SAHPRA 052/2023
SALARY LEVEL: 11(R788 910 to R837 326 per annum Total Cost To Company)
CENTRE: Pretoria
REQUIREMENTS:
• 4-year bachelor’s degree in pharmacy, a. Proof of registration as a Pharmacist must accompany your application if you have a B-Pharm degree
• Minimum of 5 years’ experience in the Pharmaceutical industry or GMP environment
• Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspections within a regulatory environment
• Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Comprehensive and sound knowledge of all relevant legislation, protocols, 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). * Resilience. * Delivery of service objectives with professional excellence and efficiency. * Ability to make effective decisions by using evidence and knowledge to support accurate, expert 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 pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA
• Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured
• Perform Pre- and Post-Registration inspections on information submitted in a medicine application dossier
• Perform Once-Off evaluation on information submitted by HCR (Applicants)
• To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively
• Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP/GWP 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
• 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 SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues
• To provide advisory support to key stakeholders, including participation in Regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge
• Record statistics of generated and peer-reviewed reports
• Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for audit purposes
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 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 October 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 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.
INSPECTOR EVALUATOR (OFFICE BASED)
Ref No.: SAHPRA 051/2023
SALARY LEVEL 11(R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• 4-year bachelor’s degree in pharmacy. a. Proof of registration as a pharmacist must accompany your application if you have a B-Pharm degree.
• 3 years’ experience in a pharmaceutical industry post community service, preferably GMP
• Extensive knowledge of GxP regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment
• Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Comprehensive and sound knowledge of all relevant legislation, protocols, 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, expert 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:
• To evaluate applications from HCRs and manufactures for the introduction of new medicine in line with the Medicine and Related Substances Act, No. 101 of 1965.
• To perform evaluations of once- off deviations by HCR or manufacturers
• To evaluate type 1 and type 2 variations as per guidance SAHPS-INSP-GMP-13
• To perform desktop reviews/ assessments for manufacturing and testing facilities, thus reducing duplication and frequency of inspections.
• To assess and evaluate the applications for Post Importation Testing exemptions.
• To evaluate and issue GMP and CPP certificates applications.
• Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP Guidelines as adopted by SAHPRA.
• To work closely across inspection teams, SAHPRA departments and external regulators to ensure evaluation activities are planned and communicated effectively.
• To support inspectors by providing relevant and timely information related to any inspections that are to be carried out.
• 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.
• Liaise with inspectors across internal departments.
• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.
• Record statistics of generated and peer-reviewed reports
• Attend on-the-job training and apply continuous professional development principles to ensure knowledge remains relevant and current in line with any regulatory requirements.
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 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 October 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 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.
INSPECTOR EVALUATOR (OFFICE BASED)
Ref No.: SAHPRA 051/2023
SALARY LEVEL 11(R788 910 to R837 326 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• 4-year bachelor’s degree in pharmacy. a. Proof of registration as a pharmacist must accompany your application if you have a B-Pharm degree.
• 3 years’ experience in a pharmaceutical industry post community service, preferably GMP
• Extensive knowledge of GxP regulations and industry practice, as well as substantial experience of undertaking GxP inspections within a regulatory environment
• Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Comprehensive and sound knowledge of all relevant legislation, protocols, 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, expert 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:
• To evaluate applications from HCRs and manufactures for the introduction of new medicine in line with the Medicine and Related Substances Act, No. 101 of 1965.
• To perform evaluations of once- off deviations by HCR or manufacturers
• To evaluate type 1 and type 2 variations as per guidance SAHPS-INSP-GMP-13
• To perform desktop reviews/ assessments for manufacturing and testing facilities, thus reducing duplication and frequency of inspections.
• To assess and evaluate the applications for Post Importation Testing exemptions.
• To evaluate and issue GMP and CPP certificates applications.
• Evaluate Standard Operating Procedures (SOPs) of Inspectorate for compliance with GMP Guidelines as adopted by SAHPRA.
• To work closely across inspection teams, SAHPRA departments and external regulators to ensure evaluation activities are planned and communicated effectively.
• To support inspectors by providing relevant and timely information related to any inspections that are to be carried out.
• 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.
• Liaise with inspectors across internal departments.
• Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the inspectorate.
• Record statistics of generated and peer-reviewed reports
• Attend on-the-job training and apply continuous professional development principles to ensure knowledge remains relevant and current in line with any regulatory requirements.
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 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 October 2023 at 16H00.
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 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.
DATABASE ADMINISTRATOR
Ref No.: SAHPRA 049/2023
SALARY LEVEL 10: R692 830 to R735 329 per annum (Total cost to company)
CENTRE: Pretoria
REQUIREMENTS:
• 3 Year National Diploma/NQ Level 6 in Information Technology specializing Software Development
• Two (2) to 7 years in database design, implementation, and support.
CORE COMPETENCIES AND TECHNICAL PROFICIENCIES:
Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. * Preparation and management of strategic plans, business plans and budgeting. * Performance measurement skills. * Self-motivated and able to work independently. * Ability to manage a variety of cross-functional team members. * Competent in problem solving and team building. * Information evaluation. * Decision making. * Objectivity. * Resilience. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Interpersonal skills. * Assertiveness. * Ethical behaviour. * Customer service. * Planning and organising skills.
DUTIES:
Designs data structures to deliver enterprise grade database design. * Analyzing user / project requirements and creates an appropriate database design, in conjunction with other developers, according to best practice and organizational initiatives and objectives. * Contributing in all phases of the development lifecycle and designs all necessary detailed flow charts and input-output forms/reports.
Completes database solutions according to user requirements / project charter and best practice, ensuring the best possible performance, quality and responsiveness of applications. * Delivering database within the specified timeframes. * Performing database quality assurance, bug-fixing, and upgrades to enhance system security and efficiency. * Ensuring optimal performance in terms of successful deliveries, reliability percentages, accomplishment rate (Original Requirements vs. Development Plan vs. Final deliveries), accomplishment time, system multi-tasking ability and system ability to address multiple issues simultaneously.
Transforming database designs and specifications into prototypes and programming integration with other systems. * Testing with user and obtaining sign-off.
Provides accessible and responsive user support. * Adhering to the call logging procedure. * Providing assistance and/or coaching users, as required.
Adheres to best practice and company policy and standards. * Collaborating with business analysts and developers to produce software designs. * Liaising with technical writers to create documentation for user support. * Maintaining and updating coding practices and documentation.
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 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).
CLOSING DATE: 26 October 2023 at 16H00.