Quality Investigation Approver – Quality Assurance

Pfizer; India; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Pfizer India seeks an experienced Quality Assurance investigator to independently review and approve deviations, investigations, OOS/OOT events, and complaints. You will assess strategies, data integrity, and documentation, applying robust root cause analysis and various investigation tools to ensure scientifically justified conclusions.

The role requires 6–10 years in QA, QC, sterile manufacturing, or investigation management, with Six Sigma/Lean or risk-management certifications preferred.

Qualifications

• B.Pharm, M.Pharm, M.Sc. (Microbiology/Chemistry), Biotechnology or Pharmaceutical Sciences with 6–10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing or Investigation Management.
• Experience with deviation management and CAPA processes.
• Ability to perform rigorous root cause analysis and data review.
• Experience with regulatory compliance (USFDA, MHRA, EMA, CDSCO).

Responsabilités

• Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological, and manufacturing investigations.
• Evaluate investigation strategies to ensure thorough fact-finding and root cause identification.
• Assess data integrity, documentation accuracy, and investigation completeness to support conclusions with evidence.
• Review the use of investigation tools (5-Why, DMAIC, Fishbone, FTA, Human Error Reduction, Risk Assessment).
• Challenge unsupported assumptions and bias to drive fact-based decisions.
• Review and approve CAPAs for effectiveness, proportionality, and sustainability.
• Ensure GMP, data integrity, and regulatory compliance; support audits and inspections.
• Collaborate with Manufacturing, Microbiology, Engineering, Validation, Quality Control, and Technical Services to drive timely closure of investigations.

Connaissances

Quality Assurance

QMS

Deviation Management

Root Cause Analysis

CAPA Management

Data Integrity

GMP Compliance

Regulatory Compliance

Audit Readiness

Technical Writing

Sterile Manufacturing Knowledge

Technical Writing

Documentation Review

Sterile Manufacturing Knowledge

Quality Systems Oversight

Formation

B.Pharm/M.Pharm/M.Sc. (Microbiology/Chemistry)/Biotechnology/Pharmaceutical Sciences

M.Pharm

M.Sc. (Microbiology/Chemistry)

Biotechnology

Pharmaceutical Sciences

Description du poste

**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