Requirements:
Applicants must have a Matric certificate and an Advanced Certificate: Pharmacy Technical Support qualification and be registered with the South African Pharmacy Council (SAPC) as per the current Pharmacy Act Regulations.
Experience:
- A minimum of two (2) years’ experience practising as a Pharmacy Technician/PostBasic Pharmacist Assistant.
- Knowledge of medical products quality assurance, including interpretation, evaluation, and analysis of laboratory testing reports and informing decision-making.
Competencies, Knowledge and Skills:
*Comprehensive and sound knowledge of relevant legislation, protocols, regulations, and guidelines about the Medicines and Related Substances Act, 101 of 1965, as amended. *Good verbal and numerical reasoning skills to allow analysis and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management 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. *Working knowledge of MS Office. *Valid driver’s licence. *Ethical behaviour and adherence to the SAHPRA code of conduct.
Duties:
- Ensure that all imported health products possess applicable SAHPRA authorisations, e.g., license, product authorisation, certificate, or permit, before release into the Republic.
- Stop non-compliant health product shipments from entering the country and ensure that necessary processes are undertaken.
- Collaborate with border control agencies for the control of health products.
- Refer any deviations that require Regulatory Compliance Management intervention to the relevant SAHPRA unit as per the prescribed procedure.
- Develop, review, and ensure implementation of approved Standard Operating Procedures (SOPs) for release/detention or denial of health products at the approved port of entry.
- Work with Border Management Authority (Port Health) and Customs in evaluating, processing, and deciding on compliance status and outcome for imported health products.
- Maintain records by recording and daily filing in the required format of all import-related documents.
- Conduct all activities within approved processes of the Regulatory Compliance Unit and report to the Manager, including needed improvement measures, monthly.
- Report performance weekly, Regulatory Compliance at SAHPRA’s Head Office.
- Submit weekly work plan and output to the Manager: Regulatory Compliance (quantitative and qualitative reports).
- Participate in monthly meetings with relevant stakeholders, e.g., Port Health, Customs.
- Prepare reports for the consideration of your Supervisor, Unit Manager, and Senior Manager.