Sr Engineer QA Cleaning Validation

Pauwels Consulting; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a senior expert to support a production and supply chain facility in cleaning validation and regulatory compliance. You will act as an SME, ensuring quality oversight and driving continuous improvement across validation activities.

Ideal candidates hold a Master’s in a scientific field, with 8+ years in pharma/chemical industries, and fluency in English and Dutch. This role emphasizes risk-based decision making and cross-functional collaboration with MSAT and

Qualifications

• Master's degree in a scientific field or equivalent experience.
• 8+ years in the pharmaceutical or chemical industry.
• Expert knowledge of cleaning validation compliance including EU cGMP, ICH Q7, and 21 CFR Parts 211.
• Experience with quality risk management approaches such as ICH Q9.
• Analytical thinker with a strong quality attitude and the ability to make risk-based decisions.
• Fluent in English and Dutch.

Responsabilités

• 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.

Connaissances

Cleaning validation

Regulatory compliance

cGMP knowledge

ICH Q7

ICH Q9

21 CFR Part 211

Risk-based decision making

Fluent English

Dutch language

Formation

Master's degree in a scientific field

Description du poste

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.