Supply Operations Quality Senior Specialist

Pfizer; Johannesburg; On-site; ZAR 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Johannesburg seeks a Supply Operations Quality Senior Specialist to ensure compliance with regulatory standards and manage quality operations. The candidate will assist in maintaining product quality, prepare for inspections, and oversee contractor operations. A Bachelor's degree in Science or Pharmacy and Quality Assurance experience are essential. This role offers an opportunity to influence quality processes in a dynamic environment.

Qualifications

• Bachelor's degree in Science or Pharmacy required.
• Experience in Quality Assurance roles is necessary.
• Familiarity with handling product complaints.

Responsibilities

• Maintain compliance with Regulatory Authority regulations.
• Assist the Responsible Pharmacist with quality compliance.
• Manage commitments related to quality activities.

Skills

Quality Assurance

Regulatory Compliance

Good Distribution Practices

KPI Monitoring

Education

Bachelor's degree in Science or Pharmacy

Job description

Job Title: Supply Operations Quality Senior Specialist

Location: Gauteng, Johannesburg | Deadline: August 30, 2025

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Position Responsibilities

• Maintain compliance with Regulatory Authority / Board of Health (BoH) Regulations.
• Support product quality and compliance of authorized activities to meet BoH expectations.
• Assist the Responsible Pharmacist (RP) with Pfizer Product Quality compliance issues.
• Ensure procedures are in place to manage falsified medicinal products in the supply chain.

Governance & Internal Organization

• Monitor KPIs with Senior Management, identify trends and improvement opportunities.
• Assess new local regulatory requirements.
• Implement Global Standard Operating Procedures (GSOPs) timely.

Development and Maintenance of Quality Culture

• Implement training programs for employees involved in distribution tasks.
• Maintain competence in Good Distribution Practices (GDP) through regular training.

Inspection and Internal Audit

• Prepare for and coordinate regulatory inspections and internal audits.
• Assist in CAPA plan implementation and ensure completion within timelines.

Commitment Tracking

• Manage commitments related to quality activities.

Change Management

• Manage changes in GxP-related activities (planned, permanent, temporary).

Product Quality Assurance & Operations

• Notify management of deviations and issues impacting marketed products.
• Participate in Quality Review Team meetings for cross-functional input.

Market Actions

• Support local actions during AQRT meetings, including recalls and CAPAs.

Deviation and CAPA Management

• Investigate deviations and track CAPAs until resolution.

Product Complaint Handling

• Ensure effective handling of product quality complaints.

Market Returns

• Support evaluation of returned goods.

Contractor Management

• Oversee Pfizer quality operations at contractors.
• Maintain quality agreements and support RQA audits.
• Report concerns or deviations with contractors.

Annual Product Quality Reviews (APQR)

• Prepare and review APQR reports.
• Manage timelines and review comments.

Education and Experience

• Bachelor's degree in Science or Pharmacy.
• Experience in Quality Assurance roles.
• Background in handling product complaints.
• Experience in completing/reviewing APQRs.