Senior Documentation Specialist

4 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Job Description

The Senior Documentation Specialist will play a crucial role in supporting Chiesi Corporate R&D Functions and Affiliates at a global level in procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and the implementation of Chiesi quality standards in managing Policies, Guidelines, SOPs, keeping them aligned to GXP (GCP/GLP/GMP/GDP/MD/GVP) 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 of Quality documentation system.
  • Participate in global governance teams as a key user on EDMS to keep it aligned to 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.
  • Support Affiliate and corporate end users in creating, revising, and withdrawing 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 and support Global R&D QA in inspection organizational aspects.
  • Support Qualified Persons in preparing and sending requested documents to regulatory authorities (AIFA) for new implementation or inspection follow-up.
  • Archive Global R&D QA department.
Requirements
  • At least 3 years of 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.
Education

Master's degree in life sciences (e.g. Pharmaceutical Chemistry, Biology etc.).

Languages

Fluent in written and oral English.

Technical Skills
  • Good computer skills, proficient with Microsoft Office applications/software.
  • Previous experience in EDMS use is preferable.
Soft Skills
  • Planning and organizational skills.
  • Problem-solving.
  • Strategic thinking.
  • Communication skills.
  • Goal orientation.

Chiesi Group offers a dynamic, fast-growing, challenging, and friendly environment. We believe our people are our most valuable asset, which is why we invest in continuous training, learning, and development. We strive to promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to give our best. That is why we offer flexible working approaches, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.

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