Global R&D Quality Assurance Specialist

1 settimana fa


Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pieno

We are looking for a talented Senior Documentation Specialist to support our Global R&D Functions and Affiliates at a global level in procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and implementing Chiesi quality standards in managing Policies, Guidelines, SOPs, keeping them aligned to GXP requirements.

Main Responsibilities:

  • Harmonize procedural documents for affiliates and corporate at a global level to meet regulatory requirements of Quality documentation systems.
  • Take part in global governance teams as a key user on EDMS to keep it aligned to the regulatory requirements for procedural documentation management.
  • Verify workflows within the EDMS for compliance with internal procedures (Quality Check) and manage Templates and Modules in EDMS.
  • S Support affiliate and corporate end-users on creation, revision, 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 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 and Support Global R&D QA in the inspection organizational aspects.
  • Support Qualified Persons in preparing and sending requested documents to regulatory authorities for new implementations or inspection follow-up.
  • Archive Global R&D QA department.

Required Skills and Qualifications:

  • At least 3 years' experience within R&D in a pharma company, particularly in Quality & Compliance groups.
  • Knowledge of GXP Regulations and Quality Standards.
  • Good knowledge of quality documentation management.
  • Electronic systems management experience is preferable.

What We Offer:

You would join a dynamic, fast-growing, challenging, and friendly environment. In Chiesi, we believe that our people are our most valuable asset, so we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying attention to the quality of our working environment and collective well-being.

We offer flexible working approaches, remote work, support in relocation processes, tax assistance services for foreign colleagues, and many other people-care services.



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