Quality Investigation Approver – Quality Assurance

Pfizer; Visakhapatnam; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Pfizer Visakhapatnam seeks a qualified QA investigator to independently review deviations, OOS/OOT, and investigations, ensuring robust scientific rationale and regulatory compliance. You will validate data integrity and drive timely CAPA closure with cross-functional teams.

Ideal candidates hold a pharm degree with 6–10 years in QA/QC or investigation management, and have Six Sigma, Lean, or risk-management certifications. Equal opportunity employer.

Qualifications

• Experience with quality investigations and CAPA processes.
• Knowledge of GMP and regulatory expectations (USFDA, MHRA, EMA).
• Strong analytical writing and data review capabilities.

Responsibilities

• Independently review and approve deviations, OOS/OOT, and investigations.
• Ensure scientific rationale, data integrity, and regulatory compliance.
• Coach teams on root cause analysis and CAPA effectiveness.
• Collaborate with QA, Manufacturing, Microbiology, and Validation teams.
• Support audits and regulatory inspections with prepared evidence.

Skills

QMS Awareness

CAPA Management

Root Cause Analysis

Regulatory Compliance

Data Integrity

GMP Compliance

Audit Readiness

Technical Writing

Documentation Review

Problem Solving

Education

B.Pharm

M.Pharm

M.Sc. (Microbiology/Chemistry)

Biotechnology

Pharmaceutical Sciences

Tools

Quality Systems Tools

Deviation Management

Job description

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.