QA Specialist – Pharmaceutical Quality Assurance

About the role

Provide quality assurance expertise, guidance and support to operational activities to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.

Key responsibilities

• Review batch records and related activities (PIT, reference standards ordering, import permits, method transfer, sample and temperature checks) to enable timely market release of finished goods.
• Conduct Product Quality Reviews and compile PQR reports for product renewals.
• Perform artwork review.
• Raise, investigate and resolve quality investigations (deviations, complaints, CAPAs, non‑conformances) in collaboration with third parties and operational units.
• Create and maintain GxP documentation and conduct self‑inspections and supplier/third‑party assessments.
• Propose and monitor actions to improve and maintain quality standards.
• Provide QA/QC support for product launches and ensure KPI delivery.
• Coordinate with external functions such as distributors, analytical laboratories and customers.
• Manage goods for destruction, perform product return evaluations and determine disposition.
• Handle technical product complaints and deliver training to sustain continuous quality improvement.
• Uphold corporate citizenship and enforce the Company Code of Conduct.

Required profile

• Minimum 3 years experience in the pharmaceutical industry (quality assurance, quality control, registration or production).
• B. Pharm qualification; registered pharmacist with the South African Pharmacy Council.
• Fluent in English.
• Strong analytical thinking, problem‑solving and planning abilities.
• High compliance orientation and effective communication skills.
• Commitment to continuous learning and self‑awareness.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• GxP quality systems understanding.
• Document management expertise.
• Regulatory compliance awareness.
• Experience with batch record review and product quality reviews.