Document Control Coordinator

Location: Belgrade, Central Serbia, Serbia

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Requisition Number: 1041

Position Title: Document Control Coordinator

External Description:

SUMMARY: The Document Control Coordinator, Process Management, is responsible for supporting the development and maintenance of GxP Quality Management Documents (QMDs) and Worldwide’s Quality Management System (QMS). The individual performs document control activities, develops tools and ensures consistency and compliance with applicable standards. The individual assists Process Owners and functional collaborators with procedural document development in alignment with Worldwide’s procedures for QMD lifecycle management.

RESPONSIBILITIES:

  • Serves as a champion of Worldwide’s QMS by participating and encouraging a strong quality culture
  • Performs document control activities throughout the GxP QMD lifecycle, including but not limited to supporting the development, deployment, revision, retirement, archiving of QMDs
  • Supports tracking, and reporting of metrics for the document control and internal compliance functions
  • Contributes to preparation for the QMD Governance Committee (QMD-GC) meeting; may be assigned administrative duties regarding QMD-GC quorum management, minutes and archiving
  • Assists with the maintenance of the QMD Master Index, SOP Master Index, eQMS data entry, QMD deviation routing, tracking and archiving, and with other QMD management trackers and tools
  • Supports the process for external dissemination of Worldwide’s QMDs
  • Collaborates with internal stakeholders to ensure compliance with the QMS and QMD lifecycle procedures
  • Executes individual goals for and supports team objectives of the QA document control organization
  • May participate in other departmental or cross-functional initiatives, as assigned
  • Perform other duties as assigned

 

OTHER SKILLS AND ABILITIES:

  • Communicates professionally, effectively, clearly and consistently, both verbally and in writing
  • Demonstrates a client-focused approach to work
  • Demonstrates critical thinking skills and ability to appropriately triage requests and concerns and escalate them
  • Demonstrates a detail-oriented work style, following requests and assignments to closure
  • Demonstrates a courteous, results-oriented commitment to build positive work relationships
  • Manages workload priorities and keeps supervision informed of challenges and availability
  • Works with a sense of urgency, recognizing and delivering time-sensitive deliverables by deadlines
  • Works with limited supervision and has a flexible approach to work assignments
  • Provides constructive input on processes and adapts to organizational changes

REQUIREMENTS:

  • Bachelor’s degree in relevant discipline preferred; 3+ years of document control experience in a scientific, engineering or other technical field required
  • Ability to read, write and speak fluent English required
  • Experience managing procedural documents, such as SOPs, forms and templates, within last 2 years required
  • Strong Microsoft application skills, including in Excel, Outlook, PowerPoint and SharePoint required
  • Excellent Microsoft Word skills, including building and formatting forms, templates and related documents
  • Strong organizational and time management skills required
  • Experience with electronic Quality Management Systems (eQMS) an asset
  • Working knowledge of GxP regulations preferred
  • Understanding of the drug development process preferred
  • Domestic and international travel may be required (less than 10%)

#LI-KP1 

City:

State: Vojvodina

Employment Type: Regular

Community / Marketing Title: Document Control Coordinator

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Belgrade, RS

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