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,...
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Applicants must have a Matric certificate and an appropriate three-year National Diploma at NQF Level 6 as recognised by the South African Qualifications Authority (SAQA) in Life/Natural Sciences/Quality Management or Technical Related.
Certificate in ISO 9001, including lead auditor certificate. A valid driver’s licence is required. A South African Auditor and Training Certification Authority registration will be an added advantage
EXPERIENCE:
Minimum of three (3) years post qualification experience in Quality Assurance within healthcare, regulatory environment, Pharmaceutical and/or Medical Devices sector. Knowledge of Regulatory requirements.
Experience in implementation and maintenance of Quality Management System. Knowledge of ISO 17025 will be an added advantage.
DUTIES:
Implementation and maintenance of the Quality Management System (QMS): Assist the QMS Manager with the maintenance of quality management system, Ensure maintenance of ISO 9001 Certification, Ensure that the implemented system is measured, monitored, and maintained for continuity, Ensure QMS governance and operational documented information.
Document and Records Management: Ensure documents are properly reviewed, approved, and updated, Ensure accessibility, version control, and archival of regulatory documents.
Compliance and auditing: Conduct QMS Internal audits, Perform routine spot checks to ensure adherence to documented procedures, Identify deviations from established procedures and initiate corrective/preventive actions, Ensure that all corrective and preventive actions are effectively implemented and documented, Monitor compliance with procedures and timelines, Accurate inputs to management review, Maintenance of related records, Conduct QMS Awareness/Training, Ensure QMS activities align with best practices for quality assurance, Report on the performance of the quality management system and recommend enhancements.
Training and Support: Training SAHPRA staff on QMS requirements and quality awareness, Provide guidance to Programmes and Units on quality-related processes, Provide guidance to SAHPRA staff to ensure adherence to quality policies and procedures.
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