Global Validation Lead: Transport & Process Validation

Pauwels Consulting; Geel; Sur place; EUR 85 000 - 120 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking an expert to oversee validation activities for transport and CMOs-manufactured products. You will ensure validation lifecycles, protocols, and risk assessments meet regulatory expectations and support audits.

You will collaborate with cross-functional teams, lead validation milestones, and serve as a technical contact for regulatory submissions and inspections.

Qualifications

• 8+ years of experience in validation and qualification, focusing on equipment qualification, requalification, and shipping validation.
• Expert knowledge of the Validation Lifecycle Approach and risk-based validation methodologies.
• Fluent in English with excellent written and oral communication skills.

Responsabilités

• Develop, review, and approve transport validation plans, protocols, risk assessments, and reports for global distribution.
• Oversee external qualification and validation packages from CMOs to ensure adherence to corporate standards.
• Perform validation impact assessments for change controls, deviations, audit findings, and CAPAs.
• Support process validation and CPV strategies for outsourced products.
• Represent the organization as a technical expert during health authority inspections and internal quality audits.
• Collaborate with cross-functional core teams to ensure validation milestones are met within project timelines.

Connaissances

Validation expertise

Regulatory experience

Description du poste

Pauwels Consulting is seeking an expert to oversee validation activities for transport and CMOs-manufactured products. You will ensure validation lifecycles, protocols, and risk assessments meet regulatory expectations and support audits.

You will collaborate with cross-functional teams, lead validation milestones, and serve as a technical contact for regulatory submissions and inspections.