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