For Lonza AG in Switzerland, we are looking for a Document Controller (m/f/d).
Establish and maintain an efficient document control system, ensuring the accurate storage, retrieval, and distribution of company documents.
Develop and implement document control procedures to meet regulatory requirements and industry best practices.
Collaborate with cross-functional teams to review, revise, and approve documentation, ensuring accuracy, completeness, and adherence to regulatory guidelines.
Maintain document control databases, tracking systems, and electronic repositories to ensure version control and access controls are properly managed.
Ensure proper organization and filing of documents, maintaining a logical and easily navigable structure.
Conduct regular audits and inspections of documents, identifying and addressing discrepancies or non-compliance issues promptly.
Train employees on document control processes, systems, and best practices, ensuring adherence to established procedures.
Collaborate with internal and external stakeholders to coordinate document reviews, approvals, and revisions within specified timelines.
Support the preparation and execution of regulatory inspections and audits related to document control processes.
Stay updated on industry trends, regulations, and guidelines related to document control, making recommendations for process improvements as needed.
Functie-eisen
Bachelor's degree in a relevant field such as pharmacy, life sciences, or a related discipline.
Proven experience in document control for CAPEX projects within the pharmaceutical industry, with a strong understanding of GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and other relevant regulations.
Experiences with document control systems (Kneat or similar)
Excellent organizational skills and exceptional attention to detail.
Strong written and verbal communication skills in English, with the ability to effectively interact with individuals at all levels of the organization.
Proficient in Microsoft Office Suite and other document management tools.