Specialist - GMS documentation Control

Position Summary

This position supports the GMS Documentation Lead in implementing, maintaining, and continuous improvement of the GMS core processes (documentation control, retention, and change control processes, as well as the training process and management system (MS) - implementation process) and the computerized systems used to support them. Work on projects for the continuous improvement and maintenance of workflows and eDMS electronic tools (e.g. QDOK). Management of tasks in the area of GMS documentation, in particular supporting and guiding process owners and SMEs in the creation, revision, and implementation of new or revised controlled documents.

Key Responsibilities Tasks performed regularly which form the essential characteristics of the position.

Support/execution of following activities within the MaCoSe/ GMS Documentation and Training Office within the Global Management System (GMS) and the respective legacy systems

• Maintain the documentation control, retention and change control processes and associated tools.

• Monitor, evaluate and implement applicable external normative and regulatory requirements according to specific task assignment

• Maintain, and improve computerized document control systems QDOK/ Windchill (e.g., user management, troubleshooting (first-level support), user training)

• Routine update review of controlled documents within GMS and the respective legacy systems (CQMS/ IMS) as part of the Periodic review.

• Participate in projects for the continuous improvement and maintenance of workflows and eDMS electronic tools (e.g. QDOK/ Windchill), and harmonization/ retirement of legacy CQMS/ QMS NA site libraries and onboarding of business areas as required.

• Perform Document Change Requests and associated tasks within eDMS, conduct Formal Document Reviews; participate in Improvement of GMS controlled documents.

• Maintain the translation process for GMS controlled documents, including administration of necessary in alignment with the Corporate Labelling & Translation Office as needed.

• Support GMS functions (e.g., MSR, PO) in documentation development activities upon request (e.g., consultancy regarding development of a new controlled document)

• Preparation and check of Local Implementation Requests (LIR) including document change activities

• Support tasks related to regulatory training process and MS implementation processes and associated tools, as needed.

• Develop and analyses KPIs and metrics to evaluate documentation control, document retention and document change control processes and associated tool

• Create controlled documents (e.g., SOPs) according to specific task assignment.

• Prepare analyses, (status) reports, and presentations on documentation control, retention, and change control processes (e.g., as input to management review)

• Administration of electronic platforms used by the department for information sharing and document storage (e.g., MS-Teams Team / MS- SharePoint/ MS-boards).

• Attend, participate and prepare meetings as requested e.g. team meetings, 1o1s, support meetings, town halls etc.

• Ensuring tasks are completed according to defined timelines.

• Maintain training evidences for all completed training assignments.

Qualifications Required:

• Completed scientific, medical or technical education at a technical college or university. • In total at least 8 years working experience

• At least 8 years of professional experience in the field of medical devices / pharmaceuticals • Preferably work experience in a multinational company

• Functional Knowledge- - Basic knowledge of the applicable normative and legal requirements for the medical device/pharmaceutical industry - - Applicable normative requirements that are the basis for FME certifications and management systems (e.g., ISO 13485, ISO 9001, ISO 14001, GxP, MDSAP) Electronic document control systems and/or integrated software solutions for management