Sr Engineer QA Cleaning Validation
Il y a 6 jours
Geel, Antwerpen, Belgique
Pauwels Consulting
Temps plein
90 000 € - 120 000 € Contrat
Gratuit avec email ou Google
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Gratuit avec email ou Google
Our client, a leading pharmaceutical organization, is seeking a senior expert to support their production and supply chain facility. This role focuses on providing quality oversight and acting as a subject matter expert for cleaning validation activities to ensure regulatory compliance and reliable supply.
Responsibilities
- Assure that all cleaning validation related regulatory and procedural requirements are fulfilled.
- Provide strategic input to the compliance improvement plan for cleaning validation.
- Maintain quality oversight on cleaning validation actions within systemic compliance programs.
- Review and approve validation documents such as SOPs, risk analyses, validation protocols, and trend reports.
- Collaborate with MSAT and operations teams to introduce new cleaning validation concepts and methodologies.
- Provide guidance on cGMP aspects for new projects and participate in multi-functional teams to achieve departmental objectives.
Requirements
- You have a Master's degree in a scientific field or equivalent experience.
- You bring 8+ years of experience in the pharmaceutical or chemical industry.
- You possess expert knowledge of cleaning validation compliance including EU cGMP, ICH Q7, and 21 CFR Parts 211.
- You have experience with quality risk management approaches such as ICH Q9.
- You're an analytical thinker with a strong quality attitude and the ability to make risk-based decisions.
- You are fluent in English and Dutch.
Nice to Haves
- Experience with the introduction of new cleaning validation concepts and methodologies.