Quality Investigation Approver – Quality Assurance

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About the role

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 ca

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