Documentation Specialist
On-siteWaterford, Munster, Ireland
Job Summary
Manage the complete GxP documentation lifecycle, including creation, revision, and obsolescence processes, while collaborating across departments to ensure content accurately reflects business needs. Ensure documentation compliance with regulatory requirements by reviewing accuracy, completeness, and adherence to established writing rules. Collect, prioritize, and manage documentation change requests to keep content current, control document distribution according to classification levels, and maintain onsite archives aligned with Global procedures. Support internal and external audits by ensuring required documents are readily retrievable and advise stakeholders on update needs. Maintain a lean documentation package by identifying redundancies and duplication.
Required Qualifications
- Background in documentation management, quality assurance, or regulatory compliance within a GxP environment
- Familiarity with Quality and Documentation Management Systems
- Fluency in English
- Knowledge of GxP documentation requirements and regulatory standards
- Understanding of documentation lifecycle management principles
- Proficiency with documentation management systems
- Strong writing and editing capabilities
Desired Qualifications
- Strong attention to detail and commitment to accuracy
- Excellent collaboration and communication abilities across diverse teams
- Ability to prioritize and manage multiple documentation projects simultaneously
- Problem-solving mindset with a focus on continuous improvement
- Proactive approach to identifying and addressing documentation gaps
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