Description

You will support the QA Engineering department in ensuring that qualification regulatory and procedural requirements are met throughout the lifecycle of manufacturing systems at the Geel site. You'll review and approve qualification documents and records, collaborate with engineering teams, and provide cGMP guidance.

Requirements

• University/Bachelor’s degree or equivalent
• Experience in chemical/pharmaceutical industry with equipment qualification
• Knowledge of cGMP regulations and guidelines
• Ability to translate technical information for various organizational levels
• Ability to estimate urgency, criticality, and impact of decisions

Responsibilities

• Review and approve qualification documents and quality records (SOPs, user requirements, risk analyses, test plans, change controls, CAPAs)
• Participate in engineering teams for new/upgraded systems and processes
• Provide advice on qualification activities and guard cGMP aspects
• Address and follow up deviations during qualification execution
• Communicate quality compliance and planning status to QA team members