Quality Investigation Approver – Quality Assurance
Core
Review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations to ensure scientific robustness and regulatory compliance.
Role type
Senior Quality Investigation Approver (QA)
Builds
High-quality investigations, robust root cause identification, and effective CAPAs for pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
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
Preferred skills
Six Sigma, Lean, Risk Management, Human Performance, Investigation Excellence
Technologies
5-Why Analysis, DMAIC, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction tools, Risk Assessment methodologies
Responsibilities
Independently review and approve investigations; Evaluate investigation strategies; Assess data integrity and documentation accuracy; Review application of investigation tools; Challenge unsupported assumptions; Assess product quality and business risks; Review and approve CAPAs; Ensure compliance with GMP and regulatory requirements; Drive investigation quality through collaboration; Identify investigation trends; Provide coaching and mentoring; Support internal and regulatory audits.
Seniority
Senior, hands-on IC