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.

 Requirements:

• 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.

Main Accountabilities:

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.

 3.     QMS

• 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

E-mail:  elzet.rusch@ceva.com