Documentation Control

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.