Analytical Method Validation Specialist
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Analytical Method Validation Specialist
Eurofins
Wavre, Belgium
Key Responsibilities
Analytical Method Validation Documentation
Author and maintain validation-related documentation including:
- Validation protocols.
- Validation reports.
- Amendments.
- Risk assessments.
- Scientific rationale reports.
- Technical instructions.
- Periodic review documentation.
- Raw data review documentation.
- Comparability protocols and reports.
- QC material qualification documentation.
Validation Project Coordination
Coordinate validation activities across multiple stakeholders.
Collaborate with laboratories, project teams, quality representatives, and statisticians.
Monitor validation studies and experimental progress.
Coordinate pre-tests, validation studies, data collection, and reporting activities.
Analyze validation results and ensure appropriate documentation of outcomes.
Quality Systems Support
Support and coordinate quality events linked to validation activities, including:
- Deviations.
- Change Controls (CC).
- Corrective and Preventive Actions (CAPA).
Participate in investigations and associated meetings.
Ensure compliance with internal quality systems and GMP expectations.
Review & Compliance Activities
Participate in peer review and quality review of validation documentation.
Contribute to maintaining the validated state of analytical methods.
Support risk-based decision making for method lifecycle management.
Continuous Improvement
Participate in operational excellence and continuous improvement projects within QC Operations.
Identify opportunities to enhance validation processes, documentation quality, and operational efficiency.
Qualifications
- Master’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related scientific discipline.
- Minimum 3-5 years of experience in pharmaceutical Quality Control, Analytical Development, Validation, or Quality Assurance.
- Strong experience with analytical method validation in a GMP-regulated environment.
- Experience authoring technical and validation documentation.
- Experience with Change control, Deviation Management and CAPA management.
- Fluent communication skills in English. French is a plus.
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