Global R&D QA, Senior Documentation Specialist

Date: 30 Sep 2024

Department: Global R&D Quality Assurance

Team: Quality

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees. 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.

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.

Who we are looking for

Purpose

The Senior Documentation Specialist will 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

• Support the Global R&D Training and Documentation Unit Head in the harmonization of procedural documents for affiliates and corporate at global level to meet regulatory requirements of Quality documentation system.
• 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.
• Verify the workflows within the EDMS for compliance with internal procedures (Quality Check) and manage the Templates and Modules in EDMS.
• Support Affiliate and corporate end users on creation, revision, withdrawal of procedural documents, ensuring their release in EDMS according to the company standards.
• Train the users on EDMS at corporate and global level.
• Manage the distribution of SOP/GL/Policies at 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 them with Senior management.
• Oversee SOPs periodical review to keep procedural documentation update, in compliance with quality requirements.
• Properly retrieve, review and deliver in timely manner the requested documents during audits and/or regulatory inspections and Support Global R&D QA in the inspection organizational aspects.
• Support Qualified Persons in the preparation and sending requested documents to regulatory authorities (AIFA) for new implementation or inspection follow-up.
• Archive Global R&D QA department.

Experience Required

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 the 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

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 colleagues and many other people-care services.