Permanent - Product Quality Review Officer - Ekurhuleni (East Rand) - South Africa

Job Purpose

• To coordinate, prepare, review, and maintain the Annual Product Review (APR) or Product Quality Review (PQR) for pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality management systems.
• The role ensures continuous monitoring of product quality, process consistency, and identification of opportunities for continual improvement.

Key Responsibilities

Annual Product Review Activities

• Develop and maintain the Annual Product Review schedule.
• Collect, compile, and analyze manufacturing and quality data for all products.
• Prepare Annual Product Review (APR) or Product Quality Review (PQR) reports within established timelines. .

Data Collection and Analysis

• Review and trend:
• Batch manufacturing records.
• Batch packaging records.
• Process validation status.
• Analytical testing results.
• Product quality trends.
• Critical Process Parameters (CPPs).
• Stability study results.
• Out-of-Specification (OOS) results.
• Out-of-Trend (OOT) results.
• Deviations.
• Change controls.
• Corrective and Preventive Actions (CAPAs).
• Customer complaints.
• Product recalls (if applicable).
• Returned products.
• Environmental monitoring results
• Equipment qualification and maintenance data.
• Training in 1SO 22000 auditing  will be an added advantage

Compliance Responsibilities

• Assist during regulatory audits by providing APR/PQR documentation.

Minimum Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.

Experience

• Minimum 2 years of pharmaceutical Quality Assurance or Quality Control experience.
• Experience with data trending and statistical analysis is an advantage.