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,...
Assist with allocation of applications and query responses to Evaluators and Quality Control within the agreed timelines.
Capture evaluation reports on the shared drive and update databases/trackers to ensure traceability and transparency.
Capture evaluation reports for peer review and/or adjudication.
Monitor and record evaluators’ capacity and follow up on outstanding evaluations.
Track application status and provide regular updates to the Portfolio Coordinators.
Compile basic statistics and performance reports for the Business Unit.
Support compliance checks to ensure use of the latest Quality Management Systems -controlled templates and adherence to Standard Operating Procedures.
Provide administrative support during internal and external audits (including ISO 9001:2015).
Liaise with internal stakeholders (Evaluators, Technical Screeners, Portfolio Coordinators) and assist with applicant queries where applicable .
Perform general administrative duties related to workflow management and record management.
Qualification :
Matric certificate and appropriate National Diploma or Bachelor’s degree in Natural Sciences, Health Sciences, or related field at NQF level 6 or 7 as recognised by South African Qualifications Authority (SAQA).
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