Key Responsibilities

• Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations to ensure scientific robustness and regulatory compliance.
• Evaluate investigation strategies to ensure thorough fact-finding, evidence gathering, and identification of scientifically justified root causes.
• Assess data integrity, documentation accuracy, and investigation completeness to ensure conclusions are supported by objective evidence.
• Review the application of investigation tools including 5-Why Analysis, DMAIC, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction tools, and Risk Assessment methodologies.
• Challenge unsupported assumptions, weak rationales, and bias to drive fact-based decision making.
• Assess product quality, patient safety, process, compliance, and business risks associated with investigation events.
• Review and approve CAPAs to ensure actions are proportionate, effective, sustainable, and aligned with identified root causes.




• Ensure compliance with site procedures, Quality Management System requirements, current GMP expectations, and global regulatory requirements.
• Drive investigation quality and on-time closure through effective collaboration with Manufacturing, Microbiology, Engineering, Validation, Quality Control, and Technical Services teams.
• Identify investigation trends, recurring events, systemic gaps, and opportunities for continuous improvement.
• Provide coaching and mentoring to investigation owners on root cause analysis, scientific rationale development, technical writing, and investigation best practices.
• Support internal audits, regulatory inspections, customer audits, and remediation activities related to investigations and CAPAs.

Key Deliverables
• High-quality investigations approved within established timelines.
• Improved effectiveness and robustness of root cause identification.
• Reduction in repeat deviations and

📌 Quality Investigation Approver – Quality Assurance (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam