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Documentation Specialist

Job description

A World Leading Biotechnology Company are hiring a Documentation Specialist in North Dublin.

 

As Documentation Specialist you’ll

  • Provide compliant, accurate and timely documentation support
  • Generate and approve of all key documents supporting the program schedule
  • Coordinate and manage approval of key project documents
  • Manage Live Documentation updates from Operations floor
  • Development of site system for the tracking of documentation progress
  • Turnaround and issue documentation as per Operations Schedule
  • Manage and implement on the floor documentation control system
  • Work with various Subject Matter Experts to ensure technical documentation updates are approved
  • Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s)
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements
  • Work closely with QA, Supply chain and Operations core functions

 

Perfect Person for the Job

  • Minimum Level 6 in a relevant Qualification
  • Experience Working in a Pharmaceutical GMP regulated industry
  • High level technical writing skills
  • Experience working with GMP Documentation Management Systems
  • Advanced PC skills (Excel, MS Access, Word, PowerPoint)
  • Familiarity with automated approval systems (Trackwise / Documentum)

 

If interested in this job Apply with your CV to Evan Long - Apply TODAY!!

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