# Microbiology Investigation Reviewer

**Company**: Pfizer
**Location**: Vizag, India
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Associate-Manager-Quality-Investigation_4966352?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_fc05c0e1-7e1

## Description

We are seeking a Microbiology Investigation Reviewer to independently review and challenge microbiological deviation, OOS/OOT, contamination, environmental monitoring (EM) excursion, sterility assurance, and objectionable organism investigations.

**Key Responsibilities:**

- Independently review and challenge microbiological 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.

- 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.

- 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

## Skills

### Required
- 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

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Associate-Manager-Quality-Investigation_4966352?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)