Associate Manager-Quality Investigation

Pfizer; India; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Pfizer is seeking a qualified professional to independently review complex microbiological investigations and drive robust root cause analysis. You will partner with multiple technical teams to ensure data integrity and regulatory compliance across sterile manufacturing environments.

The role emphasizes scien­tific rigor, quality culture, and CAPA effectiveness, with focus on continuous improvement and inspection readiness. On Premise work location in India.

Qualifications

• Bachelor/Master level education in pharmaceutical/science field with relevant sterile manufacturing exposure.
• Experience in microbiology quality investigations and regulatory compliance.
• Strong capability in using scientific reasoning, data interpretation and risk assessment.
• Familiarity with cGMP and global regulatory expectations (FDA/EMA/MHRA/PIC/S/WHO).

Responsibilities

• Independently review and challenge microbiological deviation, OOS/OOT, contamination, EM excursion and sterility 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 methods.
• Assess risks to product, process and patient and ensure mitigation plans.
• Review proposed CAPAs to address true root causes and prevent recurrence.
• Ensure investigations comply with cGMP and regulatory expectations from global authorities.
• Collaborate with Microbiology, Manufacturing, Engineering, Validation and Quality teams.
• Coach investigators on scientific reasoning, technical writing and best practices.
• Identify recurring trends and opportunities for continuous improvement in microbiological quality systems.
• Support contamination control strategies and aseptic processing improvements.

Skills

Quality Assurance

Quality Management Systems

Microbiological Investigations

Root Cause Analysis

Risk Management

Data Integrity

Regulatory Compliance

Technical Report Review

Education

B.Pharm

M.Pharm

M.Sc. Microbiology

Biotechnology

Pharmaceutical Sciences

Related discipline

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 .

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