A Documentation Specialist is required for a biotech in West Cork. The successful candidate will provide compliant, accurate and timely documentation support to the Restructuring team. The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within the Restructuring Group responsible for the decommissioning and deletion activities associated with legacy products on site.
- Active member of the cross functional Restructuring Team, providing support, guidance and expertise to ensure the success of the group.
- Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you.
- Updating/deletion of documents through the MIDAS system.
- Preparation of change control documentation on TrackWise System.
- Tracking of GCM tasks on TrackWise System.
- Processing of documentation through the Change Control System.
- Regular updates to Tier boards with various metric information such as Incidents, Investigations, CAPAs, GCM tasks, EHS actions, Safety metrics, etc.
- Generation and control of Purchase Orders on SAP.
- Responsible for supporting a culture of Continuous Improvement by deploying Six Sigma tools within the Restructuring group.
- Coaching others by sharing their skill-set and expertise.
- Reports to the Area Lead.
Qualifications & Experience:
- Minimum Leaving Certificate with a high level of achievement.
- Desirable: Qualification in a science/engineering/technical subject.Multi-tasking in a fast-paced project environment.
- At least three years experience in the Pharmaceutical industry or a similar regulated environment.
- Knowledge and experience of GMP, GDP and DI in a pharmaceutical environment.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
- Desirable: Evidence of Continuous Personal Development.
- Desirable: Six Sigma Yellow Belt.
- High level technical writing skills and good organization skills.
- Demonstrated ability to realize improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Desirable experience – SAP, MIDAS, TrackWise, Change Control.