JOB OFFER

JOB DETAILS

Title:
Document Controller
Location:
Sligo
Job Type:
Sligo

Document Controller

GerTEK Project Management & Technical Services are an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are accepting applications for our Document Controller role based in Sligo.

Job Description

  • The Document Controller will support the QA and Validation team within a highly regulated environment.
  • Maintenance of modules in ISOtrain, updating grace days, adding new SOPs to modules.
  • Crediting training in ISOtrain
  • Generating reports in ISOtrain
  • Issuing QuickSign documents for signature
  • Issuing Logbooks and other document types, batch records and controlled forms.
  • Issuing IRF forms to SMEs
  • Maintenance of the master signature log
  • Audit Support
  • Filing and maintenance of doc storage area.
  • Document updates (Compiling CR package) as required
  • Logging of Original hard copy protocols, Reports, ECMs & Events to Cage Area.
  • Logging of above when removed from Cage Area.
  • Uploading of Hard copy Lifecycle documents into Attache – Process at early stages.
  • Issuance of C & Q Protocols and NPI protocols for execution – both manual & attache protocol
  • Reconciliation of returned Protocols etc in Logbook.

Education & Key Requirements

  • Educated to Degree Level or equivalent
  • Minimum of 3years relevant experience.
  • Proficient with MS Office Suite and Adobe PDF software
  • Self-starter and strong attention to detail and proven ability to produce results on strict deadlines
  • Ability to multitask and work under pressure
  • Thorough understanding of quality systems and cGMP’s.

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