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.…