Documentation Control

5-7 Years

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Early Applicant

Job Description

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.