SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) - INSPECTOR: GMP

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REQUIREMENTS:
• Four (4) year bachelor’s degree in Pharmacy, Pharmaceutical Science, Chemistry, Medicine, Veterinary, Biological Science and Biomedical Science. 
A proof of registration as a pharmacist must accompany your application if you have a B-pharm degree [Current Designation Letter]. 
• Minimum of 5 years’ experience in the pharmaceutical industry or GMP environment (post community service). 
• Extensive knowledge of GMP regulations and industry practice, as well as substantial experience of undertaking GMP inspection within a regulatory environment. 
• Sound knowledge of the medicines and Related Substances Act 101 of 1965 as amended and all regulation pertaining to the Act. 
• Every Inspector shall be furnished with certificate signed by the Director-General and stating that they have been authorised as an Inspector under this Act. 
 
KNOWLEDGE AND SKILLS: *Comprehensive and Sound knowledge of all relevant legislation, regulations and guidelines pertaining to the Medicines and Related Substances Act 101 of 1965. *Good verbal and numerical reasoning skills to allow analyses and interpretation of written and numerical data. *Good communication skills (verbal, written, conflict management and resolution). *Delivery of service objectives with professional excellence and efficiency. *Ability to make effective decisions by using evidence and knowledge to support accurate, expect 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 drivers’ license. *Ethical behaviour and adherence to the SAHPRA Code of Conduct. 
 
DUTIES * Inspect Pharmaceutical manufacturing sites for compliance with good manufacturing practices as accepted by SAHPRA. *Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicine for exportation to South Africa are manufactured. Perform Pre- and Post-registration inspection on information submitted in a medicine application dossier. *Perform once off evaluation on information submitted by HCR (Applicants). *To work closely across inspection teams, SAHPRA departments and External regulators to ensure inspection activities are planned and communicated effectively. * Evaluation Standard Operation Procedures (SOPs) of inspectorate for compliance with GMP/GWP Guidelines as adopted by SAHPRA. * To contribute to the inspectorate’s compliance management process by ensuring that the instances of suspected or known non-compliance are handled in the appropriate manner. *Prepare report for SAHPRA and relevant advisory and the Finance department. *Liaise with inspectors from international regulatory authority. *Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate. *Interview members from the industry to discus SAHPRA Board resolutions and requirements of the Medicines and Related Substances Act, No. 101 of 1965 [and medicines quality issues]. *Provide advisory support to key stakeholders, including participations in regulatory meetings and conferences external presentations all while demonstrating sound industry and technical knowledge. *Record statistics of generated and peer-reviewed reports. Manage the associated risks and Audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection-related resources and that all relevant records and evidence is sufficiently maintained for Audit purpose.

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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 license where applicable. 
• Applications without the aforementioned documents/information 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 applications will be accepted. CVs 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: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 07 March 2023 at 16H00.