Manufacturing Validation Coordinator Pharma

Job Description Your role as Manufacturing Validation Lead In this position, you safeguard the quality and compliance of validation activities within an international pharmaceutical context. You guide validation and qualification activities for transport processes and products manufactured by external manufacturing partners. In doing so, you act as a key point of contact for quality-related validation questions and support teams with complex dossiers. You work closely with external production partners, quality departments, and international stakeholders. With your expertise, you ensure that processes comply with applicable GMP and GDP requirements and are well-prepared for audits, inspections, and registration procedures. Your responsibilities: Drafting, reviewing, and approving validation documentation. Evaluating qualification and validation dossiers from external manufacturing partners. Supporting process validation, shipping validation, and transport validation during study phases. Assessing changes, deviations, audits, and CAPAs. Approving CPV reports and contributing to APQR reviews. Acting as a validation SME during audits and inspections. Monitoring compliance with GMP, GDP, and broader quality requirements. Your profile: You work in a structured manner, maintain an overview of multiple projects, and communicate smoothly with international stakeholders and external partners. You make decisions independently and know how to identify and address risks in a timely manner.