ADMINISTRATIVE EMPLOYEE (QUALITY MANAGEMENT SYSTEMS)
Ref.No .: SAHPRA 21/2021
The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established under the Medicines and Related Substances Act, 1965, (Law No. 101 of 1965) and subsequent amendments, to provide for monitoring, evaluation, regulation, investigation, inspection, registration and control of medicinal products, scheduled substances, clinical trials and medical devices and related matters of public interest.
REQUIREMENTS:
A national diploma (NQF level 6), in business management / quality management or equivalent.
An undergraduate degree will be an added benefit in addition to at least five (5) years of experience in managing quality assurance in a business environment.
Knowledge and understanding of ISO 9001: 2015.
The implementation of ISO 9001 or the auditing certificate will be an added benefit.
SKILLS / SKILLS
Strong administrative and organizational skills.
Willingness to work extended hours if and when required.
Ability to communicate fluently in English (both written and spoken).
Decision making ability.
Critical thinking and problem solving skills.
Planning and coordination skills.
Ability to influence others and manage conflicts when needed.
Ability to tolerate stress and work under the pressure of time.
Guided deadline.
Attention to details.
Team player and can work independently.
DUTIES:
Manages and coordinates the administration function of the office of the quality management unit: Establishes the strategy of the content management function:
Provide administrative support for the development, maintenance of the quality management system.
Ensuring the accuracy of the Quality Management Unit’s standard operating procedures, oversees implementation and compliance.
Management and facilitation of the quality documentation system.
Log management.
Support the corrective action request program by capturing, monitoring and collecting data for reporting.
Assistance in analyzing business processes and internal audits, including evaluating and implementing proposed process changes.
Ensure adequate monitoring mechanisms, processes, documentation and control points for the successful execution of key quality management projects.
Respond and work closely with others regarding deviations, complaints, CAPAs, change controls.
Offer secretarial services to committees related to the quality management unit when needed. * Development and implementation of an effective office administration system for the QMS office.
INSTRUCTIONS FOR CANDIDATES: All applications must:
Be presented with a cover letter that clearly reflects the job name and job reference number, be signed, accompanied by a full CV, the names of 3 reviewers, and recently certified copies of ID and qualification (s).
Applications without the above will not be considered. If you have a foreign qualification, it must be accompanied by a South African Qualification Authority (SAQA) assessment certificate.
A separate application must be completed for each post. SAHPRA will not be liable in the event that applicants use an incorrect reference number or no reference number in their applications.
Applications should be emailed to [email protected] including the required certified documentation as indicated. DO NOT MAKE INQUIRIES AT THIS ADDRESS.
Late or faxed applications will not be accepted. CVs will not be returned. Applications received after the closing date will not be considered.
Further communications will be limited to the selected candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your question as rejected.
Applicants are expected to be available for selection interviews at a date, time and place determined by SAHPRA.
Applicants should note that further checks will be carried out once they are selected and that their appointment is subject to positive outcomes on those checks, which include security clearances, verification of qualifications, criminal records, credits, citizenship status and previous employment.
SAHPRA is guided by the principles of Equity of Employment. Applicants with disabilities are encouraged to apply and an indication to this effect will be welcome. SAHPRA reserves the right to fill vacancies or not.
Closing date: 02 July 2021