Project Document Controller
Summary
An experienced Document Controller is required as part of a 6-month contract due to a critical expansion project on site in Swords. The candidate will be required to have meticulous attention to detail, excellent communication skills, and the ability to work independently as well as cross functionally with a number of teams involved in the project. Although not limited to, the key responsibility of this position will be working with SME's to create and edit documentation for the expansion project and manage both the control and approval of the associated documents.
Key Responsibilities
Day-to-day responsibilities are focused on the control and tracking of documents. Specifically, you'll number documents and input technical revisions, perform compliance checking, filing and organizing, documentation auditing, and report on document status and distribute documents as required.
Manage Operations/Operational Duties
- Frontline enforcement of approved document control procedures across the project organisation and interface with other project participants and team members
- Maintenance of the document database and associated project documents
- Undertakes periodic reconciliation of all batch records
- Prepares and issues logbooks to departments
- Review of SOP's, forms, etc for compliance with documentation templates
- Main contact for archival and retrieval for all GMP documentation for site
- Ensure completed GMP records are filed and archived as per procedures
- Writes procedures relevant to documentation management systems and document control.
- Administrative activities to support Regulatory requirements for provision of declarations and obtaining certs
Manages information/Provide information
- Compiles monthly Periodic Review data for metrics and review at monthly Quality Council meetings
- Provides training on Document Management systems and procedures.
- Manages documentation trackers with respect to Batch Record issue and reconciliation
Manage People/Interactions with People
- Liaise with all departments to ensure that documents are controlled consistently
- Provides training to staff from different functions on document management procedures as required
- Communicates document issues
- Communicates status of documents when requested
Education/Experience
- Technical qualification in Science or Engineering or qualification appropriate to the position
- A minimum of 1 years-experience within a documentation management role of a pharmaceutical operation
- Experience with DCA/SAP/Trackwise preferred
- Working knowledge of GMP and compliance pertaining to GMP and EHS
- Excellent PC skills, MS Word, Excel, Powerpoint, Email and Calendar
- Proven ability to multi-task and work to tight deadlines
- Exposure or previous project management experience a distinct advantage
- Ability to consistently meet multiple and often conflicting deadlines.
- Strong written and verbal communication skills
- Self-starter and strong attention to detail and proven ability to produce results on strict deadlines
If you are interested please click 'Apply' or contact Dominic on 01-645-5254 for further info.
