Quality Investigation Approver – Quality Assurance

Overview

Review, challenge, and approve quality investigations and CAPAs to ensure scientific robustness, regulatory compliance, data integrity, and effective root-cause identification. Drive investigation quality, timely closure, continuous improvement, and inspection readiness while coaching investigation owners and collaborating across technical and quality teams.

What you'll do

• Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations.
• Evaluate investigation strategies, fact-finding, evidence gathering, root causes, documentation accuracy, data integrity, and investigation completeness.
• Review the application of 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.
• Collaborate with Manufacturing, Microbiology, Engineering, Validation, Quality Control, and Technical Services teams to drive investigation quality and on-time closure.
• 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.
• Drive high-quality investigations approved within established timelines, improved root-cause robustness, reduced repeat deviations, enhanced CAPA effectiveness, improved compliance, strengthened inspection readiness, reduced investigation closure cycle time, development of investigation review best practices and a lessons-learned repository, and improved quality culture.

What you'll need

• B.Pharm, M.Pharm, M.Sc. (Microbiology/Chemistry), Biotechnology, or Pharmaceutical Sciences.
• 6-10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing, or Investigation Management.
• 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.
• 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.

Nice to have

• Certification in Six Sigma, Lean, Risk Management, Human Performance, or Investigation Excellence.

Details

• Location: Vizag, India.