In partnership with its client Kenny-Whelan & Associates is currently sourcing for a Documentation Specialist for the North Dublin area.
Profile of Role:
The Documentation Specialist will provide compliant, accurate and timely documentation support. The Documentation Specialist is accountable to ensure the timely generation and approval of all key documents supporting the program schedule. Primary responsibilities include: coordinating and managing approval of key project documents, developing a site system for the tracking of documentation progress; generation of metric reports. Works with moderate work direction and is skilled and knowledgeable to the position.
Main duties and responsibilities:
- Responsibility for the timely, accurate and efficient management of documents including access and revision control.
- Manage “Live” Documentation updates from the various Departments
- Turnaround and issue documentation as per Department Schedules
- Manage and implement documentation control system
- Drive the Documentation Life Cycle System to ensure documents are approved as per Scheduling requirements.
- Work with various Subject Matter Experts to ensure technical documentation updates are approved.
- Creation and revision of Standard operating Procedures (SOPs) Work Instructions (WI’s) as required
- Work closely with QA, Supply chain and Operations core functions
- Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
Qualifications & Skills:
At minimum Level 6 in a relevant Qualification eg: Engineering, Science or similar
Advanced PC skills such as Excel, MS Access, Word, PowerPoint
Trackwise, Documentum etc. or other automated document management systems
Key Competencies & Experience:
- Self-motivated with excellent organizational skills
- Experience Working in a Pharmaceutical GMP regulated industry essential
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team in a cross functional collaborative environment
- High level of attention to detail
All applications will be treated with the strictest confidence
For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]