# Quality Assurance and Control **Company**: Pfizer **Location**: Vizag, India **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Quality-Investigation-Approver---Quality-Assurance_4965624?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_96b39da8-04b ## Description We are seeking a highly skilled professional to join our Quality Assurance and Control team in Vizag, India. **Job Summary:** As a member of our Quality Assurance and Control team, you will independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations to ensure scientific robustness and regulatory compliance. **Key Responsibilities:** - 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 ## Skills ### Required - 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 ### Nice to have - Six Sigma - Lean - Risk Management - Human Performance - Investigation Excellence --- Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Quality-Investigation-Approver---Quality-Assurance_4965624?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)