JOB FOCUS

The SOQ Hub Quality Specialist will be responsible for supporting, maintaining, and managing critical quality operations within the hub to ensure compliance with both Pfizer and Regulatory Authority expectations.

The SOQ Hub Quality Specialist will oversee tasks related to Good Distribution Practices (GDP), GDP Admin batch reviews, Complaint records processing, and other quality management processes within the Hub.

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES

• Conduct detailed reviews of all administrative batch documentation in compliance with local market regulatory requirements, Good Distribution Practices (GDP), and Pfizer quality standards.
• Monitor and document batch records, ensuring accuracy, completeness, and traceability of all transactional data related to product quality.
• Coordinate with cross-functional teams to ensure timely completion of batch reviews and resolution of any discrepancies, minimizing impact on distribution timelines.
• Manage the triage of product quality complaints received from the markets within the specified timelines.
• Classify the product complaints received and forward them to the appropriate manufacturing site responsible for the investigation, via the global complaints management system.
• Ensure correct prioritization, categorization, and timely reporting of product quality complaints.
• Support the management of complaint samples and conduct the required follow-up contact attempts with the markets to obtain information related to the complaint.
• Investigate quality deviations and work with cross-functional teams to implement CAPAs.
• Participate as required in external and internal audits and contribute to the development of CAPA plans.
• Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance.
• Assist in the development or assignment of training to key stakeholders related to QMS.
• Contribute to the preparation of Periodic Quality Reviews.
• Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Pfizer Quality standards.
• Identify areas where quality processes can be optimized and propose solutions to enhance quality performance across all Hub activities.
• Participate in continuous improvement projects to streamline quality processes, enhance compliance, and improve operational efficiency within the Hub.
• Support the implementation of a quality culture and best practices within the affiliate organization

KEY PERFORMANCE INDICATORS (KPI)

• SIR deviations, Regulatory Commitments, CAPA, CR, Complaints, Batch Reviews: monitored by KPI, VM, QRM and Supplementary metrics.
• Product Complaints: minimized by resolving open complaints within specified targets.
• Change Management: implemented by closing SOQ change requests and avoiding overdue requests.
• Internal/ External Inspections: passed by avoiding critical or repeat findings.

QUALIFICATIONS

Level of Education

A minimum Tertiary Education in Science, Pharmacy or related discipline.

Experience

• A minimum of 3 years in the pharmaceutical industry and in a quality role
• Ability to make good and wise decision under pressure
• Knowledge of the GDP/GMP regulations related to the manufacture and distribution of medicinal products
• Fluent in English (Both verbal and written)
• Technical writing and reporting

COMPETENCIES – PERSONAL CAPABILITIES

• Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise.
• Takes initiative and ownership to deliver on time without compromising on quality.
• Ability to communicate effectively verbally and in writing.
• Able to demonstrate good planning and organization skills.
• Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
• High level of self- integrity and ethical conduct

  
Work Location Assignment: Hybrid

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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