Documentation Specialist

Contract
Cork, Ireland
Posted 1 year ago

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

Job Features

Job CategoryDocumentation Specialist

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