Document Controller

SimoTech requires an experienced Document Controller for a Pharmaceutical project in Dublin. Candidates must have at least 2 years’ experience working within the biotechnology or pharmaceutical industry. The position will be for a minimum of 12 months.

Key Responsibilities
  • Actively manage documents through their lifecycle, from creation through secure retention, archival, deletion, back-up, restoration/retrieval, etc.
  • Control/Track design documents, validation protocols and reports as required.
  • Coordinate the approval of SOPs on the document control system.
  • Actively contributes to continuous improvement activities.
  • Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives.
  • Assure that records are readily retrievable and in inspection-ready condition.
  • Process incoming and outgoing documents including receipt / transmittal, classification, registry, distribution, etc.
  • Develop and maintain metrics for document management and reporting to peers and leadership.
  • Control and maintain the onsite documentation archive to maintain GMP compliance.
  • Adhere to existing document management and control principles and procedures.
  • Continually identify opportunities for improvement to existing processes.
Requirements
  • A relevant third level qualification (Engineering, Science, Business).
  • A minimum of 2-3 years relevant experience within a similar or related field.
  • Working knowledge of cGMP requirements in the pharmaceutical or a similar regulated environment.
  • Excellent accuracy and attention to detail.
  • Good knowledge of relevant computer packages e.g. Microsoft Word, Excel, SharePoint, Powerpoint.
  • Proficiency in Documentum, Trackwise, Maximo or similar applications an advantage.
  • Planning and organizing skills are required to plan, execute and track commitments of Documentation Control and to adjust to changing priorities.
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.
  • Flexible working hours and location.
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