QA Product Release Lead (Port Elizabeth) at Aspen Pharma Group

Description

• To ensure the timely review, approval and release of pharmaceutical products in line with GMP, regulatory and company quality requirements. This includes coordinating with Production, QC, Warehousing and Supply Chain to resolve delays, improve release turnaround times and ensure products are released on time without compromising quality, patient safety or compliance.

Requirements

• Manage the review, approval and release of products.
• Ensure batch documentation is complete and accurate.
• Ensure products meet GMP, regulatory and quality requirements before release.
• Monitor batch release timelines and address delays.
• Set release priorities based on production and customer needs.
• Lead daily release meetings and track batch readiness.
• Coordinate release activities with Production, QC, Warehousing and Supply Chain.
• Follow up on outstanding testing, investigations and documentation.
• Escalate quality issues and release risks when required.
• Monitor release performance and OTIF targets.
• Ensure required release documents, including Certificates of Analysis, are available.
• Identify opportunities to improve the batch release process and reduce release times.

Qualification:

• Bachelor of Pharmacy (B.Pharm)
• Registration with the South African Pharmacy Council (SAPC)

Experience:

• Minimum 5–8 years' experience in a pharmaceutical Quality Assurance environment.
• Product release and batch disposition experience.

Strong working knowledge of:

• SAHPRA requirements
• PIC/S GMP, WHO GMP, EU GMP
• Good Documentation Practices (GDP)
• Quality Risk Management
• Pharmaceutical Quality Systems
• MES (if implemented)
• Serialization and supply chain quality requirements where applicable