About the Company
Join a leading global pharmaceutical manufacturer where innovation, quality, and patient safety are at the heart of every process. You will become part of a project team focused on improving sterilization processes for sterile pharmaceutical products, contributing directly to product quality and regulatory compliance.
Role Description
As a Validation Analyst, you will play a key role in a strategic validation project focused on optimizing and validating filtration processes used in the manufacturing of sterile medicines. Working closely with engineering, manufacturing, quality, and validation teams, you will investigate existing filtration systems, assess process performance, and develop validation documentation to ensure compliance with GMP and sterilization requirements.
Key Responsibilities
- Lead validation activities related to sterile filtration processes
- Investigate existing filtration systems and identify opportunities for process improvement
- Develop, execute, and review validation protocols, reports, and technical documentation
- Assess filtration performance for aqueous and oil-based pharmaceutical formulations
- Perform impact assessments and support technical investigations
- Ensure validation activities comply with GMP and internal quality standards
- Collaborate with Engineering, Manufacturing, Quality Assurance, and Validation teams
- Support risk assessments and implement appropriate validation strategies
- Analyze validation data and prepare clear technical conclusions and recommendations
- Contribute to continuous improvement of sterile manufacturing processes
Requirements
- 5+ years of experience within the pharmaceutical industry
- Demonstrated experience writing validation protocols, technical reports, and GMP documentation
- Strong knowledge of GMP and pharmaceutical validation principles
- Good understanding of sterile manufacturing processes and filtration technologies
- Knowledge of the chemistry of aqueous and oil-based solutions
- Experience with process investigations and technical problem solving
- Strong analytical skills with a structured and quality-focused approach
- Fluent in English (Dutch is considered an advantage but is not required)
58476
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Artemis Hadjidimitriou
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