Summary of position:
- At local level, provide and ensure the quality oversight of activities in a defined scope (manufacturing, warehousing, and releasing of locally manufactured products registered under Act 36 of 1947).
- Perform QA checks and release of imported products registered under Act 36 of 1947 and Act 101 of 1965.
- Be responsible for Quality documentation, e.g., SOPs, Annual Product Reviews.
- At local level, conduct internal audits of the activities and manage projects as appropriate.
- Assist QA Manager as auditor for complex / external audits.
- Matric / Grade 12
- B. Pharm degree
- Registered with the SA Pharmacy Council
- Quality Assurance experience will be an advantage (2-3 years)
- Thorough understanding of GDP/GMP
- High accuracy and attention to detail skills
- Strong work ethic.
The following would enhance your application:
- GDP / GMP Training / Certificate
- Animal Health Industry experience
- Knowledge of regulatory submissions in Botswana, Namibia, Zambia and Zimbabwe.
- Pharmaceutical production knowledge.
1. Act as Deputy Responsible Pharmacist for the entity
2. At appropriate level of Quality & Strategy:
- Implement and improve the quality system.
- Release non-GMP/GMP products and materials (including investigational products).
- Be accountable for quality-related decisions (depending on seniority level).
- Manage product-related deviation, change control and action plan processes
- Complete assigned CAPA, change control or any other assigned actions according to target dates.
- Be responsible for pharmacovigilance (product complaints and adverse drug events).
- Be responsible for the stability program.
- Write QMS documents
- Approve SOPs as applicable.
4. Community Building & activation
- Ensure continuous improvement in the production processes in conjunction with other departments.
- Build training modules and present Quality training sessions.
5. Audits & inspections
- Assist with external audits as required (contract research sites, laboratories and manufacturers).
- Assist with internal audits as appropriate.
- Conduct self-inspections
- Possibly host inspections.
Technical Skills required:
- Previous audit experience
- Technical and scientific knowledge
- Continuous improvement of processes
- Regulations’ knowledge
- Quality Management Systems knowledge
- Strong MS Office and IT tools skills
- Ability to anticipate and solve problems and queries.
Closing date for applications: 17 June 2022
Fax or e-mail applications to:
Contact: Elzet Rusch
Last update: 07/06/2022