Quality Investigation Approver – Quality Assurance

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 recurring quality events.

Enhanced CAPA effectiveness and sustainability.

Improved compliance with GMP, data integrity, and regulatory expectations.

Strengthened inspection readiness and reduction in investigation-related observations.

Improved investigation closure cycle time without compromising quality.

Development of investigation review best practices and lessons learned repository.

Improved quality culture through effective coaching and reviewer engagement.

Education Qualification

B.Pharm, M.Pharm, M.Sc. (Microbiology/Chemistry), Biotechnology, Pharmaceutical Sciences

Minimum 6-10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing, or Investigation Management.

Certification in Six Sigma, Lean, Risk Management, Human Performance, or Investigation Excellence preferred.

Required Skills

Quality Assurance

Quality Management Systems (QMS)

Deviation Management

Root Cause Analysis

Investigation Review and Approval

Corrective and Preventive Action (CAPA) Management

Risk Assessment and Risk Management

Data Integrity

GMP Compliance

Regulatory Compliance (USFDA, MHRA, EMA, TGA, CDSCO)

Audit Readiness

Technical Writing and Documentation Review

Sterile Manufacturing Knowledge

Quality Systems Oversight

Transferable Skills to Develop

Critical Thinking and Scientific Reasoning

Risk-Based Decision Making

Investigative Interviewing Techniques

Systems Thinking

Problem Solving and Analytical Skills

Data Analysis and Trending

Stakeholder Management

Influencing Without Authority

Effective Communication and Coaching

Time Management and Prioritization

Key Investigator & Reviewer Competencies

Ability to distinguish symptoms from true root causes.

Ability to identify investigation gaps and challenge weak justifications.

Strong attention to detail and data review capabilities.

Capability to evaluate investigation completeness and scientific validity.

Strong understanding of human error, behavioral factors, and organizational contributors.

Ability to objectively assess product quality and patient impact.

Fact-based decision making with strong compliance orientation.

Expertise in evaluating CAPA adequacy and effectiveness.

Strong technical writing and report review skills.

Sound judgment and decision-making abilities during complex investigations

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

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Quality Assurance and Control