Original listing text, shown exactly as published by the company.
Key Responsibilities
Environmental Monitoring Investigation Support
- Support Environmental Monitoring investigations by providing microbiological expertise and technical assessment of EM data.
- Review environmental monitoring results associated with investigation activities.
- Compile and analyse investigation data to support root cause determination.
- Perform microbial identification data reviews and support interpretation of results.
- Assist in assessing potential product, process, and facility impact resulting from EM events.
- Collaborate with cross-functional teams to support timely closure of EM investigations.
Quality Event Management
- Initiate and support Event Records (EVs), deviations, and quality investigations related to environmental monitoring and microbiological testing activities.
- Ensure quality records are completed accurately and within established timelines.
- Prepare supporting documentation, technical assessments, and investigation summaries.
- Support investigation teams by providing microbiological expertise and quality system knowledge.
- Partner with Quality Assurance to ensure compliance with site procedures and GMP requirements.
CAPA Management
- Support the development, implementation, and closure of Corrective and Preventive Actions (CAPAs).
- Track CAPA actions to completion and ensure required documentation is maintained.
- Participate in effectiveness checks and follow-up activities as required.
- Support identification and implementation of process improvements arising from investigation outcomes.
Compliance and Continuous Improvement
- Ensure compliance with GMP requirements, site procedures, and data integrity standards.
- Support internal audits, regulatory inspections, and inspection readiness activities.
- Participate in continuous improvement initiatives related to contamination control and quality systems.
- Contribute to the creation, revision, and maintenance of procedures, work instructions, and training materials.
- Promote a culture of quality and compliance within the QC Microbiology function.
Qualifications
Education
- Bachelor's degree in Microbiology, Biological Sciences, Biotechnology, or related scientific discipline.
Experience
- 3-5 years of experience within a GMP-regulated pharmaceutical or biotechnology environment.
- Experience working in a QC Microbiology laboratory.
- Experience with Environmental Monitoring programs and quality systems.
- Familiarity with deviations, Event Records, CAPAs, and GMP documentation practices.
Technical Knowledge
- Environmental Monitoring programs
- Cleanroom contamination control principles
- Microbial identification techniques
- GMP regulations and quality systems
- Data Integrity (ALCOA+)
- Root Cause Analysis principles
- Risk Assessment methodologies
- EU GMP Annex 1 requirements
Key Competencies
- Strong attention to detail
- Technical writing and documentation skills
- Effective cross-functional collaboration
- Organizational and prioritization skills
- Ability to manage multiple quality records simultaneously
- Strong understanding of contamination control and microbiological risk
Key Performance Indicators
- On-time completion of EVs and supporting investigation activities
- CAPA action completion within target timelines
- Accuracy and quality of investigation documentation
- Audit and inspection readiness
- Effectiveness of CAPA implementation and closure
.…
