Quality Assurance Product Release Pharmacist

Requirements:

• Pharm Degree. Registered Pharmacist SAPC
• Must have at least 2 years experience
• Knowledge of national and regional pharmaceutical regulatory requirements as well as ICH, WHO, PICS & South African GMP guidelines
• Must be able to work in a high-pressure corporate environment. Commercial awareness, good project management skills and an ability to adapt to changing priorities
• Very good communicator. Good communication skills and fluency in English (read, write & speak)
• High attention to detail
• Analytical thinker - Organisational and administrative skills
• Good computer literacy (MS Office 365, Excel, Word, PowerPoint, Planner, Veeva, etc.)
• Customer focus, drives results, collaborates with others, manages complexity, works under pressure, and is able to multitask and prioritize workload according to criticality
• No transportation problems in getting to the company on-site position
• Preferably someone over 35
• Advantages if worked with DSV Healthcare Solutions

Main Responsibilities:

1. Review manufacturing and packaging records for completeness, accuracy, and compliance with Good Manufacturing Practices (GMP)
2. Check that all deviations, changes, or issues during production were properly documented and resolved
3. Approve or reject batches of product based on quality and compliance
4. Sign off on Certificates of Analysis (CoA) and other key documents to authorize release
5. Ensure the manufacturing process follows regulatory requirements (e.g., FDA, EMA, TGA, etc.)
6. Make sure all processes align with internal Standard Operating Procedures (SOPs)
7. Investigate any deviations or non-conformances from quality standards
8. Ensure proper Corrective and Preventive Actions (CAPAs) are implemented
9. Evaluate proposed changes to processes, equipment, materials, or documents to ensure they don't negatively affect product quality
10. Maintain detailed and compliant documentation of QA activities
11. Prepare reports for internal use and regulatory audits
12. Work closely with manufacturing, QC (Quality Control), regulatory, and supply chain teams
13. May assist in internal audits or be involved during regulatory inspections
14. Help train other staff on GMP and quality procedures