SimoTech requires an experienced Document Controller for a Pharmaceutical project in Cork. Candidates must have at least 2 years’ experience working within the biotechnology or pharmaceutical industry.
- 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.
- 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.
- 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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