As a Documentation Specialist supporting the GMS Documentation Lead, your role involves implementing, maintaining, and continuously improving the core processes within the Global Management System (GMS). Here's a breakdown of your responsibilities:

• Maintain documentation control, retention, and change control processes and associated tools.
• Monitor, evaluate, and implement external normative and regulatory requirements.
• Manage and enhance computerized document control systems like QDOK/Windchill.
• Review controlled documents within GMS and legacy systems regularly.
• Collaborate on projects to improve workflows and electronic tools.
• Handle Document Change Requests and Formal Document Reviews.
• Coordinate translation processes for controlled documents.
• Support GMS functions in documentation development activities.
• Prepare Local Implementation Requests and conduct document change activities.
• Assist with regulatory training processes and MS implementation.
• Develop and analyze KPIs and metrics for evaluating documentation control processes.
• Create controlled documents such as SOPs.
• Generate reports and presentations on documentation control processes.
• Administer electronic platforms for information sharing and document storage.
• Attend and prepare for various meetings as required.
• Ensure timely completion of tasks and maintain training records.

Qualifications required for this role include:

• A scientific, medical, or technical education from a technical college or university.
• A minimum of 8 years of working experience, specifically in medical devices/pharmaceuticals.
• Preference for experience in a multinational company.
• Basic knowledge of normative and legal requirements in the medical device/pharmaceutical industry.
• Familiarity with electronic document control systems and management systems standards like ISO 13485 and ISO 9001.

This position offers you the opportunity to contribute to the continuous improvement of GMS processes and play a vital role in maintaining documentation integrity within the organization. As a Documentation Specialist supporting the GMS Documentation Lead, your role involves implementing, maintaining, and continuously improving the core processes within the Global Management System (GMS). Here's a breakdown of your responsibilities:

• Maintain documentation control, retention, and change control processes and associated tools.
• Monitor, evaluate, and implement external normative and regulatory requirements.
• Manage and enhance computerized document control systems like QDOK/Windchill.
• Review controlled documents within GMS and legacy systems regularly.
• Collaborate on projects to improve workflows and electronic tools.
• Handle Document Change Requests and Formal Document Reviews.
• Coordinate translation processes for controlled documents.
• Support GMS functions in documentation development activities.
• Prepare Local Implementation Requests and conduct document change activities.
• Assist with regulatory training processes and MS implementation.
• Develop and analyze KPIs and metrics for evaluating documentation control processes.
• Create controlled documents such as SOPs.
• Generate reports and presentations on documentation control processes.
• Administer electronic platforms for information sharing and document storage.
• Attend and prepare for various meetings as required.
• Ensure timely completion of tasks and maintain training records.

Qualifications required for this role include:

• A scientific, medical, or technical education from a technical college or university.
• A minimum of 8 years of working experience, specifically in medical devices/pharmaceuticals.
• Preference for experience in a multinational company.
• Basic knowledge of normative and legal requirements in the medical device/pharmaceutical industry.
• Familiarity with electronic document control systems and management systems standards like ISO 13485 and ISO 9001.

This position offers you the opportunity to contribute to the continuous improvement of GMS processes and play a vital role in maintaining documentation integrity within the organization.