Senior Documentation Specialist, Global R&D Quality Assurance
2 giorni fa
About the Job
Chiesi Farmaceutici S.P.A. is seeking a Senior Documentation Specialist to support the Global R&D Quality Assurance team in procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and the implementation of Chiesi quality standards. The successful candidate will work closely with the Global RD Training and Documentation Unit Head to harmonize procedural documents for affiliates and corporate at a global level, ensuring compliance with regulatory requirements.
Main Responsibilities
• Support the harmonization of 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 alignment with regulatory requirements for procedural documentation management.
• Verify workflows within EDMS for compliance with internal procedures and manage templates and modules in EDMS.
• Support affiliate and corporate end-users on the creation, revision, and withdrawal of procedural documents, ensuring their release in EDMS according to company standards.
• Train users on EDMS at corporate and global levels.
• Manage the distribution of SOP/GL/Policies at a global level (Corporate departments and Affiliates) and to external providers (CROs and Pharmacovigilance Service Providers).
• Extract and process quality metrics and KPIs related to procedural documentation for sharing with senior management.
• Oversee SOPs periodical review to keep procedural documentation up-to-date, in compliance with quality requirements.
• Properly retrieve, review, and deliver requested documents during audits and/or regulatory inspections.
• Support Global RD QA in inspection organizational aspects.
• Support Qualified Persons in the preparation and sending of requested documents to regulatory authorities (AIFA) for new implementation or inspection follow-up.
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