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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.
BORDER MEDICINES CONTROL TECHNICIAN x2
Ref No.: SAHPRA 057/2023
SALARY LEVEL: 7 (R384 936 – R408 560 per annum Total Cost to Company)
CENTRE: OR Tambo International Airport and Cape Town Harbour
NB: Applicants must be willing to start with Immediate effect and must be residing within the respective provinces.
REQUIREMENTS:
• Advanced Certificate: Pharmacy Technician qualification and relevant registration with SAPC
• Sound and in-depth knowledge of the regulatory compliance requirements in South Africa.
• Knowledge of medical products quality assurance including interpretation, evaluation and analysis of laboratory testing reports and inform decision making.
• Experience: A minimum of 2 years’ experience practicing as a Pharmacy Technician/Post Basic Pharmacist’s Assistant
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:
• Ensure that all imported health products for release into the Republic of South Africa possess applicable SAHPRA authorizations, e.g., licence, product authorization, certificate, or permit.
• Refer to relevant SAHPRA unit any deviations that require Regulatory Compliance Management or Inspectorate intervention.
• Stop the non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken.
• Conduct onsite inspections.
• Escalate matters to supervisors/manager.
• Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for release / denial/ detention/seizing of health products at the approved port of entry.
• Work with Border Management Agency, Port Health, Customs and Police in evaluating, processing and deciding on compliance status and outcome for imported health products.
• Participate in meetings with Port Health/ Border agencies.
• Conduct joint inspections.
• Maintain records by recording and filing daily in the required format all import related documents.
• All activities must be within approved processes within the Regulatory Compliance Unit and report to Manager on improvement measures needed monthly.
• to the allocated Medicines Control Officer: Regulatory Compliance at SAHPRA Headquarters.
• Submit weekly work-plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports).
• Submit monthly performance report aligned with unit performance measure.
• Prepare reports for consideration of your Medicines Control Officer supervisor, Unit Manager and Senior Manager.
BORDER MEDICINES CONTROL TECHNICIAN x2
Ref No.: SAHPRA 057/2023
SALARY LEVEL: 7 (R384 936 – R408 560 per annum Total Cost to Company)
CENTRE: OR Tambo International Airport and Cape Town Harbour
NB: Applicants must be willing to start with Immediate effect and must be residing within the respective provinces.
REQUIREMENTS:
• Advanced Certificate: Pharmacy Technician qualification and relevant registration with SAPC
• Sound and in-depth knowledge of the regulatory compliance requirements in South Africa.
• Knowledge of medical products quality assurance including interpretation, evaluation and analysis of laboratory testing reports and inform decision making.
• Experience: A minimum of 2 years’ experience practicing as a Pharmacy Technician/Post Basic Pharmacist’s Assistant
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:
• Ensure that all imported health products for release into the Republic of South Africa possess applicable SAHPRA authorizations, e.g., licence, product authorization, certificate, or permit.
• Refer to relevant SAHPRA unit any deviations that require Regulatory Compliance Management or Inspectorate intervention.
• Stop the non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken.
• Conduct onsite inspections.
• Escalate matters to supervisors/manager.
• Develop, review and ensure implementation of approved Standard Operating Procedures (SOPs) for release / denial/ detention/seizing of health products at the approved port of entry.
• Work with Border Management Agency, Port Health, Customs and Police in evaluating, processing and deciding on compliance status and outcome for imported health products.
• Participate in meetings with Port Health/ Border agencies.
• Conduct joint inspections.
• Maintain records by recording and filing daily in the required format all import related documents.
• All activities must be within approved processes within the Regulatory Compliance Unit and report to Manager on improvement measures needed monthly.
• to the allocated Medicines Control Officer: Regulatory Compliance at SAHPRA Headquarters.
• Submit weekly work-plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports).
• Submit monthly performance report aligned with unit performance measure.
• Prepare reports for consideration of your Medicines Control Officer supervisor, Unit Manager and Senior Manager.
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: 17 November 2023 at 16H00.