PHARMAFull time
Quality Investigation Approver – Quality Assurance
By Admin · Quality Assurance & Quality Control
VIZAG (IN)ONSITEPOSTED: 10/13/2026
PHARMAFull time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Pfizer is hiring a Quality Investigation Approver for its Quality Assurance function at the Vizag site in India. The role centres on independently reviewing, challenging and approving investigations, root cause conclusions and CAPAs, and on coaching investigation owners across manufacturing and quality teams.
ROLE DEFINITION & RESPONSIBILITIES
- •Review, challenge and approve investigations covering deviations, non-conformances, OOS/OOT, complaints, and environmental, microbiological and manufacturing events.
- •Assess investigation strategy, fact-finding and evidence gathering, and confirm root causes are scientifically justified.
- •Check data integrity, documentation accuracy and investigation completeness so conclusions are supported by objective evidence.
- •Review the application of 5-Why Analysis, DMAIC, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction tools and risk assessment methodologies.
- •Approve CAPAs, confirming actions are proportionate, effective, sustainable and aligned with the identified root cause.
- •Ensure compliance with site procedures, Quality Management System requirements, current GMP and global regulatory requirements.
- •Collaborate with Manufacturing, Microbiology, Engineering, Validation, Quality Control and Technical Services to improve investigation quality and on-time closure.
- •Identify trends, recurring events and systemic gaps, and coach investigation owners on root cause analysis, scientific rationale, technical writing and best practices.
- •Support internal audits, regulatory inspections, customer audits and remediation activities related to investigations and CAPAs.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm, M.Pharm, M.Sc. (Microbiology/Chemistry), Biotechnology or Pharmaceutical Sciences.
- Minimum 6–10 years of experience in Quality Assurance, Quality Control, Sterile Manufacturing or Investigation Management.
- Ability to distinguish symptoms from true root causes and to identify investigation gaps and challenge weak justifications.
- Strong attention to detail and data review capabilities, with understanding of human error, behavioural factors and organisational contributors.
- Ability to objectively assess product quality and patient impact and to make fact-based decisions with a compliance orientation.
- Expertise in evaluating CAPA adequacy and effectiveness, plus strong technical writing and report review skills.
- Sound judgement and decision-making during complex investigations.
PREFERRED QUALIFICATIONS
- •Certification in Six Sigma, Lean, Risk Management, Human Performance, or Investigation Excellence.
REQUIRED VERIFIED 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
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Pfizer is a global pharmaceutical company. This role is based within its Quality Assurance function at the Vizag site in India.
TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
APPLICATION ADVISORY
Lead with your hands-on experience reviewing and approving deviations, OOS/OOT and microbiological investigations in sterile manufacturing, and name the specific tools you have applied such as 5-Why, DMAIC, Fishbone and Fault Tree Analysis. Show evidence of judging CAPA adequacy and of supporting regulatory or customer audits, including work with USFDA, MHRA, EMA, TGA or CDSCO expectations. Mention any coaching or mentoring you have done with investigation owners, since the role includes reviewer engagement and technical writing support.
SPONSORED · TRAINING
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