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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - INSPECTOR: GVP
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: GVP
Salary: R692 830.00 – R837 326.00 p/a (All-inclusive)
Ref No.: SAHPRA 013/2022
Re-advertisement NB: Candidates who previously applied are encouraged to apply
CENTRE: Pretoria
REQUIREMENTS:
• Four (4) year bachelor’s degree in Pharmacy,
a. A proof of registration (Recent Designation Letter) as a pharmacist must accompany the application.
• Minimum of 5 years’ experience in the pharmaceutical industry or GVP environment.
• Extensive knowledge of GVP regulations and industry practice, as well as substantial experience of undertaking GVP inspection within a regulatory environment.
• Sound knowledge of the medicines and Related Substances Act 101 of 1965 as amended and all regulation pertaining to the Act.
• Sound and in-depth knowledge of Pharmacovigilance quality management systems and good Pharmacovigilance practices.
• Sound knowledge of regulatory scientific and technical (to assesses the quality, safety and efficacy aspect.
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 analyses 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 drivers’ license. *Ethical behavior and adherence to the SAHPRA Code of Conduct.
DUTIES * Inspect Holders of Certificates of Registration and/or companies responsible for pharmacovigilance activities locally and internationally to ensure compliance with good Pharmacovigilance Practices (GVP) as accepted by SAHPRA and other PIC/S (Pharmaceutical Inspection Co-operation Scheme) aligned regulatory agencies. * To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. * Prepare inspection reports within the defined timelines. To review and manage responses from the inspected sites within the defined timelines. To draft summary reports and recommendations for remediation and resolutions for inspected sites within the defined timelines. * To contribute to the inspectorate’s compliance management process by ensuring that the instances of suspected or known non-compliance are handled in the appropriate manner. * Provide advisory support to key stakeholders, including participating in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. * Record statistics of generated and peer-reviewed report. * Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behavior demonstrated when managing inspection-related resources and that all relevant records and evidence is maintained for Audit purposes.
REQUIREMENTS:
• Four (4) year bachelor’s degree in Pharmacy,
a. A proof of registration (Recent Designation Letter) as a pharmacist must accompany the application.
• Minimum of 5 years’ experience in the pharmaceutical industry or GVP environment.
• Extensive knowledge of GVP regulations and industry practice, as well as substantial experience of undertaking GVP inspection within a regulatory environment.
• Sound knowledge of the medicines and Related Substances Act 101 of 1965 as amended and all regulation pertaining to the Act.
• Sound and in-depth knowledge of Pharmacovigilance quality management systems and good Pharmacovigilance practices.
• Sound knowledge of regulatory scientific and technical (to assesses the quality, safety and efficacy aspect.
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 analyses 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 drivers’ license. *Ethical behavior and adherence to the SAHPRA Code of Conduct.
DUTIES * Inspect Holders of Certificates of Registration and/or companies responsible for pharmacovigilance activities locally and internationally to ensure compliance with good Pharmacovigilance Practices (GVP) as accepted by SAHPRA and other PIC/S (Pharmaceutical Inspection Co-operation Scheme) aligned regulatory agencies. * To work closely across inspection teams, SAHPRA departments and external regulators to ensure inspection activities are planned and communicated effectively. * Prepare inspection reports within the defined timelines. To review and manage responses from the inspected sites within the defined timelines. To draft summary reports and recommendations for remediation and resolutions for inspected sites within the defined timelines. * To contribute to the inspectorate’s compliance management process by ensuring that the instances of suspected or known non-compliance are handled in the appropriate manner. * Provide advisory support to key stakeholders, including participating in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. * Record statistics of generated and peer-reviewed report. * Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behavior demonstrated when managing inspection-related resources and that all relevant records and evidence is 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 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: 26 April 2023 at 16H00.
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: 26 April 2023 at 16H00.