Manufacturing Validation Lead | Pharma | Geel

Your job as Manufacturing Validation Lead

Do you want to be responsible for the quality and compliance of validation activities within an international pharmaceutical environment? As Manufacturing Validation Lead, you will guide validation and qualification activities for both transport processes and products produced by external manufacturing partners. You are an important quality voice within projects and support teams with complex validation issues. In doing so, you collaborate with CMOs, quality departments, and international stakeholders. Thanks to your expertise, you ensure that processes comply with the highest GMP and GDP standards and are ready for audits, inspections, and registrations.

Fortunately, we can count on you for:

• Drafting, reviewing, and approving validation documentation
• Assessing qualification and validation dossiers from CMOs
• Supporting process and transport validations during study phases
• Evaluating changes, deviations, audits, and CAPAs
• Approving CPV reports and contributing to APQR reviews
• Acting as validation SME during audits and inspections
• Monitoring GMP, GDP, and global quality requirements

You work in a structured manner and maintain an overview of multiple projects simultaneously. Thanks to your strong communication skills, you coordinate smoothly with international stakeholders and external partners. You make independent decisions and know how to identify and assess risks in a timely manner.

Hard skills

• Bachelor or master's degree in a scientific field
• At least 6 years of experience within validation or quality assurance
• Experience within pharmaceutical, biotech, or medical device environments
• Fluent knowledge of English, both oral and written
• Knowledge of GMP, GDP, process validation, qualification, and shipping validation