Senior Global R&D Documentation Specialist
2 settimane fa
Job Description:
The Senior Global R&D Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at a global level in procedural documentation management, EDMS configuration, and implementing Chiesi quality standards for managing Policies, Guidelines, SOPs, aligning them to GXP requirements.
Main Responsibilities:
- Support the Global R&D Training and Documentation Unit Head in harmonizing procedural documents for affiliates and corporate at a global level to meet regulatory requirements.
- Participate in global governance teams as a key user on EDMS to ensure it aligns with regulatory requirements for procedural documentation management.
- Verify EDMS workflows for compliance with internal procedures and manage EDMS templates and modules.
- Support affiliate and corporate end-users on creating, revising, and withdrawing procedural documents, ensuring release in EDMS according to company standards.
- Train users on EDMS at corporate and global levels.
- Manage the distribution of SOPs/GL/Policies at a global level and to external providers.
- Extract and process Quality Metrics and KPIs related to procedural documentation.
Requirements:
- At least 3 years' experience in R&D in a pharma company, particularly in Quality & Compliance groups.
- Knowledge of GXP Regulations and Quality Standards.
- Good knowledge of quality documentation management.
What We Offer:
Chiesi Group offers a dynamic, fast-growing, challenging, and friendly environment. We believe our people are our most valuable asset and invest in continuous training, learning, and development.
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