The Documentation Specialist will provide compliant, accurate and timely documentation support to the Restructuring team.

Responsibilities

• 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.
• Contribute to the High-Performance culture within the group by providing a flexible, accurate service to enable the achievement of site key priorities.
• The Documentation Specialist is an active member of the cross functional Restructuring Team, providing support, guidance and expertise to ensure the success of the group.
• Will participate and comply with the site 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 site Six Sigma tools within the Restructuring group.
• Coaching others by sharing their skill-set and expertise.

Qualifications & Education

• 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).
• Experience in the Pharmaceutical industry or a similar regulated environment.
• Multi-tasking in a fast-paced project environment
• Minimum Leaving Certificate with a high level of achievement.
• Desirable: Qualification in a science/engineering/technical subject.
• Desirable: Evidence of Continuous Personal Development.
• Desirable: Six Sigma Yellow Belt.
• Independent, self-confident worker with good initiative
• 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
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie