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…