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