Document Lifecycle Management: Coordinate activities including editing, printing, routing, and archiving through the Electronic Document Management System (EDMS). Shop Floor Support: Perform work within the cleanroom environment, requiring the ability to maintain gowning qualification and adhere to strict aseptic protocols. Operational Control: Issue GMP-controlled documents to relevant departments and execute the Print for Reconciliation (Pf. R) process to ensure proper archival. Compliance Oversight: Maintain the Periodic Review Process for released documents and ensure adherence to Document and Records Management policies. Strategic Representation: Represent Quality on cross-functional teams, providing training to internal customers on Document Control procedures. Continuous Improvement: Utilize your expertise to simplify systems, ensuring efficiency while fostering an engaging, safety-conscious work environment. Audit Support: Act as a Subject Matter Expert (SME) and presenter for Document Control during health authority inspections and internal audits. Who You Are. Education & Experience: You hold a Bachelor’s degree in a scientific discipline with at least 3 years of experience in the (bio)pharmaceutical industry, including knowledge of cGMP and SOPs in a manufacturing environment. Quality Mindset: You possess an unwavering commitment to quality, ensuring that every task—from document control to cleanroom operations—is executed with the highest level of integrity and compliance. Critical Thinking: You demonstrate a strong aptitude for critical thinking, with the ability to analyze complex processes, identify potential risks, and implement simplified, effective solutions. Technical Proficiency: Strong knowledge of Quality systems and cGMP regulations. Previous experience with Veeva or similar EDMS is preferred. Communication & Influence: Excellent communication skills with the ability to influence stakeholders at all levels and address the needs of diverse teams. Detail Orientation: Proven ability to prioritize multiple projects simultaneously while maintaining a high level of accuracy. Physical Requirements. Cleanroom Access: Must be able to pass and maintain gowning qualification to work in Grade C/ D (or higher) cleanroom environments. Office & Lab Environment: Work in an office setting with the ability to sit, stand, and move within the workspace for extended periods. Manual Handling: Ability to lift up to 25 lbs as required.