R&d QA Documentation Specialist

**Date**:27 Aug 2025

**Department**:Global R&D Quality Assurance

**Business Area**:Quality

**Job Type**:Direct Employee

**Contract Type**:Temporary

**Location**:Parma, IT

**_About us_**
- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas**:Discover more here**
- We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**, a recognition of **high social and environmental standards**. We are a **reliable** company that adopts and promotes a **transparent and ethical behavior** at all levels.
- We believe that the success of **Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors**. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
- In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

**_Chiesi Research & Development_**
- Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

**_Who we are looking for_**

**Purpose**
- To support Chiesi Corporate R&D Functions and Affiliates at global level in the procedural documentation management, Electronic Documentation Management System (EDMS) configuration and to support 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**
- To take part at global level of governance teams as key user on EDMS to keep it aligned to the regulatory requirements for procedural documentation management.
- Verification of workflows within the EDMS for compliance with internal procedures (Quality Check) and management of Templates and Modules in EDMS.
- To support Affiliate and corporate end users on creation, revision, withdrawal of procedural documents, ensuring their release in EDMS according to the company standards.
- To manage the distribution of SOP/Guidelines/Policies at global level (Corporate departments and Affiliates) and to external Providers (CROs and Pharmacovigilance Service Providers).
- To oversee SOPs periodical review to keep procedural documentation update, in compliance with quality requirements.
- To properly retrieve, review and deliver in timely manner the requested documents during audits and/or regulatory inspections and to support Global R&D QA in the inspection organizational aspects.
- Archivist for Global R&D QA department.

**Experience Required**
- Consolidated experience within R&D in a pharma company, preferably in Quality & Compliance groups.**Education**
- Master’s degree in life sciences (e.g. Pharmaceutical Chemistry, Biology etc.)**Languages**
- Fluent in written and oral English**Technical Skills**
- Required skills: Good knowledge of the quality documentation management and electronic systems management experience.
Preferred skills: Knowledge of GXP Regulations and Quality Standards. Good understanding of the drug development process, experience in audits and health authority inspections is a plus.**IT Skills**-
**Soft Skills**
- Communication skills
- Planning and organizational skills
- Problem solving
- Team working

**_ What we offer_**
- You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that** our people are our most valuable asset**, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular **attention to the quality of our working environment and to 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 be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colle