Our client, a leading biopharmaceutical company, is keen to hire a Documentation Specialist to join their team in Sligo on an initial 12-month contract.
This role will involve working as part of the biologics operations team.
As a Documentation Specialist, you will be responsible for the following:
- Managing 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
- Coordinate the execution of CAPA plan related to the sterility assurance of the department
- Receive, review, and format documents in preparation for the Change Request process
- Manage the site record retention process
- Assist with external audits and inspections through the coordination, preparation and compilation of document packages for audits
(Full spec available upon request)
- A third-level qualification in a science, quality or relevant discipline
- Experience working an aseptic sterile fill finish manufacturing environment or other Regulated industry
- Proficient in Microsoft Office applications
For more information on this Documentation Specialist role, please contact Chloe Somers