Documentation Control at Fresenius… · Bengaluru

Documentation Control Location: Bengaluru, KA Key Responsibilities: • Support documentation and training activities within the Global Management System (GMS) and legacy systems. • Maintain document control, retention, and change control processes and associated tools. • Support electronic document management systems such as QDOK and Windchill including user management, troubleshooting, and training. • Conduct periodic review of controlled documents and support document lifecycle management activities. • Participate in continuous improvement initiatives related to workflows, eDMS tools, and harmonization of legacy systems. • Perform document change requests, formal document reviews, and controlled document updates. • Support translation and implementation activities for controlled documents. • Prepare Local Implementation Requests (LIR) and related documentation activities. • Support regulatory training processes and associated systems/tools. • Prepare KPIs, reports, dashboards, and presentations related to documentation control and compliance processes. • Maintain electronic collaboration and document storage platforms such as MS Teams and SharePoint. • Ensure activities are completed within defined timelines and maintain training records/evidence. Qualifications: • Bachelor’s degree in Scientific, Medical, Technical, or related field. • Minimum 5 years of overall work experience. • Minimum 3 years of experience in Medical Devices or Pharmaceutical industry. • Knowledge of applicable standards and regulations such as ISO 13485, ISO 9001, ISO 14001, GxP, and MDSAP. • Experience with electronic document management systems and integrated quality management tools preferred. • Strong documentation, compliance, coordination, and communication skills.