Documentation Specialist jobs

Documentation Specialist

Location: Waterford

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About the job

Our Team

Join our Site Documentation Management team, where we play a critical role in ensuring the integrity and compliance of all GxP documentation systems. We manage the complete lifecycle of critical documentation through our Content Management Systems (CMS) and Archiving platforms, ensuring alignment with Global procedures and regulatory requirements. Our team is at the heart of quality assurance, supporting both internal operations and external audits by maintaining accurate, accessible, and compliant documentation that enables Sanofi to deliver safe, effective treatments to patients worldwide.

Main Responsibilities

• Manage the complete GxP documentation lifecycle, including creation, revision, and obsolescence processes

• Collaborate across departments to ensure documentation content accurately reflects business needs and operational processes

• Ensure documentation compliance with regulatory requirements and company standards, working with relevant subject matter experts

• Maintain a lean documentation package by identifying and eliminating redundancies and duplication

• Review and ensure accuracy, completeness, and compliance of documentation with established writing rules, including clarity and grammar standards

• Collect, prioritize, and manage documentation change requests to keep content current and aligned with evolving processes

• Control document distribution and access in accordance with information classification levels

• Manage the issue, control, and reconciliation of logbooks to ensure compliance with site needs

• Maintain onsite archives and ensure alignment between onsite and offsite archiving processes with Global procedures

• Support internal and external audits and inspections by ensuring all required documents are readily retrievable.

• Establish and maintain documentation systems, making key decisions on compliance-related actions

• Advise stakeholders on documentation update needs and document access requirements

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About You

• Experience: Background in documentation management, quality assurance, or regulatory compliance within a GxP environment; familiarity with Quality and Documentation Management Systems is a must

Soft skills:

• 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

Technical skills:

• Knowledge of GxP documentation requirements and regulatory standards

• Understanding of documentation lifecycle management principles

• Proficiency with documentation management systems

• Strong writing and editing capabilities

• Languages: Fluency in English is required

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Pursue Progress, Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But Progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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