Senior R&D QA Associate, Procedural Document Specialist

This position exists as a member of the Global R&D QA department assisting the R&D QA Quality Systems organization with management of the Document Management Systems (DMS) activities to support the R&D Quality Management System.

The Senior R&D QA Associate will be responsible for the overall content and maintenance of the DMS system on behalf R&D Quality and will coordinate document management workflow activities for personnel supported by the R&D Quality Systems organization. Providing support for global R&D and QA organization in GXP compliance related matters, including assurance that all aspects of procedural document management comply with GXPs, legal, regulatory requirements, and CSL Quality Manual requirements.

• Collaborate with global R&D functions to ensure their DMS needs are captured as required, participate in DMS initiatives, and create consistency across the CSL R&D organization.
  
• Liaise with other procedural document management contacts to share best practices and identify/leverage opportunities across Quality systems and processes.
  
• Manage procedural documents and associated documents in the DMS by: Providing Subject Matter Expert (SME) advice/assessments on procedural document management, Publishing and routing the approval of GxP procedural and associated documents in the DMS, Ensuring that properties are assigned to documents in a compliant manner, Facilitate document change control, Maintain procedural document templates for R&D, Monitoring document effective dates and facilitate periodic review/update as required, Basic system troubleshooting
  
• Support internal audits and regulatory inspections through providing readily accessible records from the DMS
  
• Provision of Quality KPI metrics related to procedural document management. This may also include follow-up with document owners to ensure review and update of documents on a timely basis
  
• Stay current with industry trends and contribute innovative ideas to enhance the overall DMS experience
  
• Support the Head, R&D Quality Systems / Manager, R&D Global Document Management Systems in day to day activities as required
  

• University degree in in a relevant business, communication, technology, science discipline or equivalent education or experience
  
• Experience in use and administration of Document Management Systems (DMS)
  
• Pharmaceutical industry experience in Quality, or R&D environment
  
• Knowledge of industry regulations; with emphasis on GxP guidelines
  
• General understanding of quality systems and appreciation of need for regulatory compliance
  
• Ability to interact, communicate and work with colleagues globally
  
• Proven experience in coordinating training and learning programs
  
• High attention to detail & strong customer focus
  
• Ability to work independently and as a team member
  
• Planning and co-ordination
  
• Written and oral communication skills, German language skills required
  
• Proficiency in document management systems, Veeva QDocs preferred