Junior Gmp Compliance Specialist

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 30-Mar-2023

**Department**: Corporate 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 30 countries with more than 6,000 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, chemical manufacturing and controls, 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) and Toronto (Canada).

Who we are looking for

Purpose

Ensuring that the Corporate R&D Quality Management System (QMS) is in compliance with Good Manufacturing Practice (GMP) requirements and with company quality standards for compliance and auditing activities

Main Responsibilities
Managing and monitoring the follow-up/non-conformities (Corrective Action Preventive Action) of GMP/Medical Device audits in the TrackWise system
Execution of first and second party GMP audits
Collecting/reviewing quality data for QMS and for Key Performance Indicators (KPIs) as per area of expertise
Supporting the preparation and managing the follow-up of regulatory authorities’ inspections as per area of expertise

**Considering the area of interest**: issuing, reviewing and monitoring the documents supporting R&D QMS, ensuring to keep them in updated status as per applicable regulatory standards
Organizing of training regarding activities and regulations pertinent to GMP aspects as per area of expertise
Managing external consultants supporting Auditing & Supplier Qualification Unit as per area of interest
Experience Required
At least 2 years of expertise in GMP quality assurance preferably in Pharma Research and Development environment
Knowledge of TrackWise system and Auditor Certification (GMP and/or ISO) are considered preferred requirements
Education

Scientific degree

Languages

**English level**: fluent

Technical Skills
Knowledge of auditing technique
Knowledge of training technique
Knowledge of GMP regulations and of the quality management systems (i.e. ISO 9001)
Soft Skills
Decision making
Goal orientation
Planning and organizational skills
Stress management
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 colleagues and many other people-care services.

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