PHARMAFull time
Associate Manager-Quality Investigation
By Admin · Quality Assurance & Quality Control
VIZAG (IN)ONSITEPOSTED: 11/2/2026
PHARMAFull time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Pfizer is seeking an Associate Manager-Quality Investigation in Vizag to review microbiological investigations and quality events in sterile manufacturing. The role applies root cause analysis, risk assessment and CAPA review to support regulatory compliance and contamination control.
ROLE DEFINITION & RESPONSIBILITIES
- •Independently examine and question microbiological deviations, OOS/OOT results, contamination events, environmental monitoring excursions, sterility assurance issues and objectionable organism investigations for scientific and regulatory soundness
- •Assess investigation strategy, data integrity and the strength of evidence so that conclusions are supported by facts and scientific reasoning
- •Lead structured root cause analysis using 5-Why, Fishbone Analysis, Fault Tree Analysis and human error reduction techniques
- •Evaluate risks to product, process, patients and compliance, and check that suitable risk mitigation is identified and implemented
- •Review proposed CAPAs to confirm they address the true root cause and can prevent recurrence
- •Ensure investigations follow cGMP, internal quality standards and regulatory expectations from FDA, EMA, MHRA, PIC/S and WHO
- •Partner with Microbiology, Manufacturing, Engineering, Technical Services, Validation and Quality teams, and coach investigation owners on scientific reasoning, critical thinking, technical writing and investigation practice
- •Identify recurring trends and systemic gaps, and support contamination control, aseptic processing and sterility assurance improvement
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm, M.Pharm, M.Sc in Microbiology, Biotechnology, Pharmaceutical Sciences, or a related discipline
- 6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management
REQUIRED VERIFIED SKILLS
Quality Assurance
Quality Management Systems (QMS)
Microbiological Investigations
Root Cause Analysis
Risk Management
Data Integrity
Regulatory Compliance (FDA, EMA, MHRA, PIC/S)
Technical Report Review and Approval
cGMP
CAPA
Sterility Assurance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Pfizer is a pharmaceutical company. This quality investigation role is based at its Vizag site in India.
TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
APPLICATION ADVISORY
Highlight your 6+ years in sterile pharmaceutical manufacturing, microbiology, quality assurance or investigation management. Show direct experience reviewing microbiological deviations, OOS/OOT results, environmental monitoring excursions, sterility assurance and contamination investigations, and name the root-cause tools you have used such as 5-Why, Fishbone and Fault Tree Analysis. Mention CAPA effectiveness, data integrity and familiarity with FDA, EMA, MHRA, PIC/S or WHO expectations.
SPONSORED · TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.