SPECIALIST - GOOD MANUFACTURING PRACTICES (GMP) X10
Two (2) year contract period subject to renewal to five (5) years
Salary Package: Grade D2 all-inclusive remuneration per annum (total cost to company)
CENTRE: Pretoria
SPECIALIST – BIOLOGICAL MEDICINE (VACCINE) CLINICAL ASSESSOR X3
Ref No.: SAHPRA 004/2024
REQUIREMENTS: Matric certificate and B. Pharm Degree with master’s degree in pharmacy (NQF level 09) as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / an MBChB degree and registration as a Medical Officer with the Health Professional Council of South Africa (HPCSA). Post graduate qualifications in virology/vaccinology or pharmacology of biotherapeutics and good project management skills is an added advantage. Have experience in biological medicines/vaccines, virology, clinical trials, safety, and efficacy determinations. A minimum of 10 years’ experience in compilation/review of product information and patient information leaflets (Vaccines and biotherapeutics). Knowledge and experience of international guidelines and regulatory standards on biological medicine dossier compilation, Clinical aspects of biological dossier review (independent/expert). Effective training/mentorship skills. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act. Knowledge of quality, safety, and efficacy aspects of medicines.
SPECIALIST – BIOLOGICAL MEDICINE (VACCINE) QUALITY ASSESSOR X3
Ref No.: SAHPRA 003/2024
REQUIREMENTS: Matric certificate and B. Pharm Degree with master’s degree in pharmacology (NQF level 09) and registration as a Pharmacist with South African Pharmacy Council (SAPC) or / PhD in Biomedical sciences or equivalent related qualification at NQF level 10 as recognised by SAQA. Post graduate qualifications in biotherapeutic/vaccine development, pharmaceutics, or regulation of biotherapeutics/vaccines. Good project management skills is an added advantage. Have expert knowledge and experience in quality aspects including chemistry, manufacturing and control of vaccines and or other biologicals. A minimum of 10 years’ experience in compilation and/or review of quality aspects of biotherapeutic/vaccine CTD dossiers. Knowledge and experience of international guidelines and regulatory standards on biological medicine dossier compilation, Quality (CMC) aspects of biological dossier review (independent/expert). Effective training/mentorship skills. Sound knowledge of the Medicines and Related Substances Act 101 of 1965 as amended and all regulations pertaining to the Act. Knowledge of quality, safety, and efficacy aspects of medicines
SPECIALIST PHARMACOVIGILANCE X2
Ref No.: SAHPRA 002/2024
REQUIREMENTS: Matric certificate and MBChB degree with Master’s degree in Public Health or Clinical Pharmacology (NQF level 09) as recognised by SAQA. Registration with Health Professional Council of South Africa (HPCSA). PhD in public health or pharmacology will be an added advantage. A minimum of 10 years’ experience in public health programmes or clinical research. Participation in local, regional or international associations or advisory bodies.
SPECIALIST - GOOD MANUFACTURING PRACTICES (GMP) X2
Ref No.: SAHPRA 001/2024
REQUIREMENTS: Matric certificate and B. Pharm with Master’s degree in Pharmacy (NQF level 09). Registration as a Pharmacist with South African Pharmacy Council (SAPC). Participation in local, regional or international associations or advisory bodies. Experience in development of policies and guidelines in the respective field. Demonstration of scientific or technical leadership in the respective field. A minimum of 10 years’ experience in manufacturing/QMS in the Health Sector, including experience of conducting and participating in GMP inspections. A relevant PhD will be an added advantage.
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence 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.
• 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.
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, certified copies of qualification(s) and Identity Document (certified within the past 3 months).
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies.
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). The closing date is the 26th of April 2024 at 16H00.
Applications must be sent to: tmotswasejane@witshealth.co.za
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