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Document Control Administrator

Job Title: Document Control Administrator
Contract Type: Permanent
Location: Cork
REF: 82310
Job Published: over 2 years ago

Job Description

Document Control Administrator

Our client, a medical device company in Cork are currently looking to recruit a Document Control Administrator for their site on a permanent contract.

Job Description / Information
  • As part of a Document Control team, be the Subject Matter Expert with regard to Acceptable Quality Standards for (PLM) Document Control and change control activities.
  • Ensure Regulatory compliance in area of Document Control and change control to cGMP?s of all medical device regulatory agencies (e.g. FDA and DEKRA)
  • As Document Control team member act as the first point of contact for daily business support issues related to QMS documents.
  • Act as a key gatekeeper or approver for all Documentation processes (procedures and records)
  • Provide support to other eSystems such as MES, GLS and Oracle
  • Champion and coach business users on GDP, PLM and change control processes to ensure users compliance to procedures and Regulatory requirements.
  • Provide support to internal and third party audits.
  • Distribute documents in-house and to vendors and assist in the supplier on-boarding process
  • Interact with offsite suppliers for Document storage and retrieval.
  • Act as site Subject Matter Expert for Item Master in Oracle
  • Provide support to NPI?s and site projects and identify best practices for future improvements
  • Execute testing for PLM system upgrades.

Minimum Qualifications
  • Good computer skills (Word, Excel & Oracle)
  • Good knowledge of ISO 9001 / ISO 13485, GMP and 21 CFR an advantage
  • Previous experience of working in an FDA regulated manufacturing environment an advantage.
  • Previous experience in an administrative role would be an advantage.

For further information on this Document Control Administrator role in Cork please contact Aisling Reardon on 091730022 /
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