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
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Quality Assurance and Control