Associate Manager-Quality Investigation

1G5 Pfizer Healthcare India Private Limited; Visakhapatnam; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Pfizer in Visakhapatnam seeks an experienced quality investigator to independently review microbiological deviations, OOS/OOT, contamination, and sterility events. You will assess investigation strategy, data integrity, and evidence to ensure scientifically sound conclusions and regulatory alignment.

Lead root cause analysis using structured tools, manage risks, review CAPAs, and collaborate with microbiology, manufacturing, and quality teams to strengthen the quality culture and inspection

Qualifications

• Education and experience in sterile pharma manufacturing and microbiology.
• Experience in quality assurance, investigations, and regulatory expectations.
• Ability to review scientific evidence and write technical reports.

Responsibilities

• Independently review and challenge microbiological deviation, OOS/OOT, contamination, EM excursion, sterility, and objectionable organism investigations.
• Evaluate investigation strategy, data integrity, and evidence adequacy to support conclusions.
• Drive root cause analysis using 5-Why, Fishbone, Fault Tree, and Human Error Reduction techniques.
• Assess product, process, patient, and compliance risks with mitigation actions.
• Review and challenge CAPAs to address root causes and prevent recurrence.
• Ensure investigations comply with cGMP, internal standards, and regulatory expectations (FDA, EMA, MHRA, PIC/S, WHO).
• Collaborate with Microbiology, Manufacturing, Engineering, Validation, Technical Services, and Quality teams.
• Coach teams on scientific reasoning, technical writing, and investigation practices.
• Identify recurring trends and opportunities for continuous improvement in microbiology quality systems.
• Support contamination control and sterility assurance improvements.

Skills

Quality Assurance

QMS

Microbiological Investigations

Root Cause Analysis

Risk Management

Data Integrity

Regulatory Compliance

Technical Report Review

Investigative Interviewing Techniques

Stakeholder Management

Effective Communication

Education

B.Pharm, M.Pharm, M.Sc. Microbiology, Biotechnology, Pharmaceutical Sciences, or related discipline

6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management

Job description

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients.

Key Responsibility

• Independently review and challenge microbiological deviation, OOS/OOT, contamination, environmental monitoring (EM) excursion, sterility assurance, and objectionable organism investigations to ensure scientific robustness and regulatory compliance.
• Evaluate investigation strategy, data integrity, and adequacy of evidence to ensure conclusions are supported by facts and scientific rationale.
• Drive effective root cause analysis utilizing structured investigation tools such as 5‑Why, Fishbone Analysis, Fault Tree Analysis, and Human Error Reduction techniques.
• Assess product, process, patient, and compliance risks and ensure appropriate risk mitigation measures are identified and implemented.
• Review and challenge proposed CAPAs to ensure they address the true root cause and are capable of preventing recurrence.
• Ensure investigations comply with cGMP requirements, 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 to strengthen investigation effectiveness and quality culture.
• Coach investigation owners on scientific reasoning, critical thinking, technical writing, and investigation best practices.
• Identify recurring trends, systemic gaps, and opportunities for continuous improvement within microbiological quality systems.
• Support contamination control strategies and continuous improvement initiatives related to aseptic processing and sterility assurance.

Key Deliverables

• Timely closure of microbiological investigations without compromising investigation quality.
• Improved effectiveness and depth of root cause analysis.
• Reduction in repeat deviations and recurring contamination‑related events.
• Enhanced quality and regulatory compliance of investigation reports.
• Improved CAPA effectiveness and sustainability.
• Strengthened contamination control and sterility assurance practices.
• Increased capability of site personnel in performing scientifically sound investigations.
• Improved inspection readiness and reduction in regulatory observations related to investigation quality.
• Development of a robust knowledge base for microbiology‑related quality events and lessons learned.

Education Qualification

• B.Pharm, M.Pharm, M.Sc. Microbiology, Biotechnology, Pharmaceutical Sciences, or related discipline.
• 6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management.

Required 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
• Transferable Skills to Develop Critical Thinking and Scientific Decision Making
• Investigative Interviewing Techniques
• Risk-Based Assessment and Prioritization
• Data Analysis and Trend Evaluation
• Technical Writing and Report Critique
• Influencing Without Authority
• Problem Solving and Systems Thinking
• Stakeholder Management
• Effective Communication and Coaching

Key Investigator & Reviewer Competencies

• Ability to distinguish symptoms from true root causes.
• Ability to challenge assumptions and identify investigation gaps.
• Strong analytical mindset with attention to detail.
• Capability to assess investigation completeness and scientific soundness.
• Ability to identify bias and ensure fact‑based decision making.
• Strong understanding of human performance and human error reduction concepts.
• Effective questioning and interviewing skills to obtain factual information.
• Capability to evaluate product quality impact and patient risk objectively.

Values/Behaviours to Develop Excellence

• Focus on what matters most.
• Measure outcomes and drive continuous improvement.
• Demonstrate scientific rigor in decision making.
• Promote a right‑first‑time investigation culture.
• Courage Speak up and challenge unsupported conclusions.
• Make quality‑based decisions using facts and data.
• Equity Demonstrate objectivity, fairness, and consistency in investigation reviews.
• Joy Foster collaboration, knowledge sharing, and continuous learning.

Work Location Assignment

On Premise 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.