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Werfen Immunoassay

6 months ago

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Company information

Company
Werfen Immunoassay
Location
España Spain
Posted
6 months ago
View all jobs at Werfen Immunoassay

Job description

Job Summary Direct responsibility for the management of IA (Immunoassay) Library, R&D, DHF electronic records system, and other IA R&D information systems. Strong collaboration with other teams in the definition and development of several tools for knowledge and information management. Key Accountabilities Library management Maintain and constantly update the Library catalog (application design, record cataloguing, vocabulary control) Provide the document supply service Manage Information sources, and implement procedures for document flow. Ensure the correct application of document management procedures to ensure compliance of documentation in the R&D department. R&D documentation management: Manage electronic records in compliance with regulatory requirements (GLP, ISO) and company procedures. Oversee documentation workflow processes, including document creation, review, approval, and archiving. Ensure data integrity and security within the electronic document management system. Work with project teams to ensure documentation standards are followed. Develop and maintain document control procedures and guidelines. Assist with audits and inspections. Training and Support Provide training and support to R&D staff on document management systems and procedures. Knowledge management: Participate in the identification and implementation of knowledge management initiatives. Research and analyze information needs of the R&D department and propose solutions. Collaboration and Communication Collaborate with cross-functional teams to ensure effective information sharing. Communicate with vendors on document management tools and software. Contribute to the development and maintenance of training materials and documentation. Qualifications Bachelor's degree in a relevant field (e.g., Information Science, Library Science, or related field). Proven experience in document management or library management. Strong understanding of document control principles and procedures. Experience with electronic document management systems (EDMS). Knowledge of regulatory requirements (e.g., GLP, ISO). Excellent organizational and communication skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite. Preferred Qualifications Experience in the pharmaceutical or biotechnology industry. Experience with IA (Immunoassay) related documentation. Familiarity with R&D processes. Experience with knowledge management systems. Strong attention to detail. Experience working with document management systems such as Veeva Vault.

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