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.
- 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 / firstname.lastname@example.org
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