Senior QA Associate - Compliance & Investigation Lead

Pfizer

Makati

Hybride

PHP 600 000 - 1 000 000

Plein temps

Il y a 10 jours

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Résumé du poste

Pfizer is seeking a Quality Assurance/Control professional to review clinical and commercial drug batches, perform sampling and statistical process control, and approve investigations to maintain cGMP compliance. You will contribute to moderately complex projects, assess Change Control impacts, and document QA deviations while ensuring global Pfizer quality standards.

The role requires strong knowledge of GMP/GxP, critical thinking, and collaboration skills.

Qualifications

  • Must understand current Good Manufacturing Practices and GxP standards.
  • Excellent analytical and problem-solving abilities.
  • Strong collaboration within teams and cross-functional groups.

Responsabilités

  • Evaluate and review clinical and commercial drug batches for compliance.
  • Perform sampling and SPC procedures to detect deviations.
  • Approve investigations and change controls per cGMP policies.
  • Contribute to projects, manage time, and draft short-term plans.
  • Assess Change Control for potential GxP impacts and document findings.
  • Investigate QA deviations and escalate to QA Lead as needed.
  • Ensure regulatory compliance with GxP and oversee site documentation.

Connaissances

Critical thinking
Team collaboration
Problem solving
GxP/GMP knowledge
Excel and Word
Proactive approach
Quality mindset

Formation

High school diploma or equivalent
Associate’s degree
BA/BS
MBA/MS

Outils

Microsoft Excel
Microsoft Word
AI tools (ChatGPT, Copilot)

Description du poste

Pfizer is seeking a Quality Assurance/Control professional to review clinical and commercial drug batches, perform sampling and statistical process control, and approve investigations to maintain cGMP compliance. You will contribute to moderately complex projects, assess Change Control impacts, and document QA deviations while ensuring global Pfizer quality standards.

The role requires strong knowledge of GMP/GxP, critical thinking, and collaboration skills.

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