Sr. Specialist, DocUnit Services

The Position

The Sr. Specialist, Doc Unit Services is responsible for ensuring the effective and efficient support of the lifecycle management of controlled and non-controlled documents in Boehringer Ingelheim (coordination, user access provision, assisting authors and signatories) via Boehringer’s electronic document management system (e-DMS). This will be performed in compliance to the predefined set of standards and agreed service level agreement of the process, while ensuring high quality of work.

Duties and Responsibilities:

  • Perform medium to complex lifecycle management processes of BI Regulations (GxP and non-GxP activities)using ServiceNow and e-DMS. As needed, support and back up the operations.
  • Conduct quality assurance check of reviewed documents prior to aproval workflow and related quality assurance tasks.
  • Ensure a timely LCM process execution and (key) user support (Veeva Vault & IDEAforCON) for any business process related questions, errors or suggestions for improvement, or any single service request.  
  • Keeps the document landscape and mode of implementation within the area of responsibility in a controlled state by supporting Authors before and during the creation process of documents
  • Ensure that work instructions and other process-related documents are up-to-date.
  • Identify improvement opportunities in the process.
  • Support projects and migration activities as needed. 
  • Follow and maintain established processes and services on operational level in coordination with Corporate Quality.
  • Assist the Head of Doc Unit Services for MSR Reporting and QA Coaching/Feedback as part of regular monthly reports. 
  • Participate in stakeholder meetings and alignments.
  • Support Onboarding Training for New Hires
  • Area Business Admin for GQ Doc Unit /Perform 2nd Level Support through escalation to 2nd and 3rd Level VQD IT Support

Requirements:

  • Graduate of Any Bachelors Degree
  • Knowledgeable in GXP and GMP.
  • Job fullfilment requires excellent knowledge and understanding of Document Lifecycle Management, related guidance and procedures, and corresponding tools used (Veeva Vault, MyServices, etc.) used for e-DMS.
  • Strong Process- and systemic thinking; technological skills in terms of related tools and technology; Good understanding of BI documents and related guidance.
  • Excellent communication and coordination skills
  • Cross functional thinking
  • Good inter-personal and cultural sensitivity
  • Team player
  • Good understanding and knowledge of process documentation and end-to-end Document Lifecycle Management
  • Ability to work across business units
  • Strong stakeholder management skills
  • Reliability

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