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Pfizer

SOQ Senior Associate

Posted 4 Days Ago
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Hybrid
Makati City, Metro Manila, National Capital Region
Senior level
Hybrid
Makati City, Metro Manila, National Capital Region
Senior level
The role involves reviewing and approving GDP documentation, assessing investigations, ensuring compliance with GDP and GxP regulations, and collaborating on projects to maintain operational goals.
The summary above was generated by AI
Use Your Power for Purpose - GDP Batch Review Team
Every day, our commitment to Good Distribution Practices (GDP) ensures that patients receive safe, effective products with integrity throughout the supply chain. We foster a science-driven, risk-based quality culture that is flexible, innovative, and always patient-focused. Your work in batch review directly safeguards compliance and strengthens trust in our global operations.
What You Will Achieve
In this role, you will:
  • Review and approve GDP documentation for commercial batches to confirm compliance with distribution and storage requirements.
  • Verify batch records and supporting evidence to ensure adherence to GDP standards and regulatory expectations.
  • Assess and endorse investigations and change controls impacting distribution processes, ensuring alignment with global quality policies.
  • Collaborate on moderately complex projects, managing timelines and prioritizing tasks to meet operational goals.
  • Evaluate Change Control activities for potential GDP and operational impacts, escalating concerns where necessary.
  • Investigate and document deviations related to distribution practices, providing clear, accurate reports for Quality Assurance oversight.
  • Ensure compliance with GDP and GxP regulations, maintaining rigorous quality review of site documentation to meet global standards.

Here Is What You Need (Minimum Requirements)
  • High school diploma (or equivalent) with 8+ years of experience, or associate's degree with 6+ years, or BA/BS with 2+ years, or MBA/MS with relevant experience.
  • Solid understanding of GDP principles, GxP regulations, and quality systems.
  • Strong analytical and critical thinking skills.
  • Ability to work effectively within cross-functional teams.
  • Proficiency in Microsoft Excel and Word.
  • Proactive approach to problem-solving and continuous improvement.

Bonus Points If You Have (Preferred Requirements)
  • Experience with quality systems and GDP compliance.
  • Strong organizational skills and attention to detail.
  • Familiarity with regulatory documentation and audit readiness.
  • Ability to mentor and review work of colleagues.

Work Location Assignment: On Premise
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

Top Skills

Excel
Microsoft Word

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