Our client, a leading biopharmaceutical company, is hiring a Documentation Specialist to join their team in Sligo on a 6-month contract.
As a Documentation Specialist, you will be responsible for the following:
- Manage the company’s document control system and change control system, ensuring compliance to site, cGMP and Regulatory requirements
- Ensure the accuracy, quality and integrity of documents
- Ensure that controlled copies of latest approved documents and drawings are available at defined locations
- Preparation of reports and metrics showing the effectiveness of the documentation system, batch release process and product release
- Receive, review, and format documents in preparation for the Change Request process
- Manage the site record retention process
- Prepare batch documentation
- Review executed batch documentation to ensure compliance to site, cGMP and Regulatory requirements
- Release approved product per agreed schedule
- Assist with external audits and inspections through the coordination, preparation and compilation of document packages for audits
Requirements
- Minimum of 2 years document control and records management experience in a Regulated industry
- Expertise with Microsoft Word with a solid understanding of the review and formatting tools
- Expertise with Outlook, Visio, Excel, PowerPoint
For more information on this Documentation Specialist role, please contact Chloe Somers
chloe.somers@collinsmcnicholas.ie
071 9140254