Product Quality

Unique Personnel boasts over 50 years (established in 1970) of personnel and staffing experience, so it's not surprising that even though our main focus has been providing on South African Staffing Solutions, we now recruit internationally for over 5000 clients

Duties & Responsibilities

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.

Desired Experience & Qualification

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.
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