PV QA Junior Specialist

Date:  May 11, 2023
Department:  Corporate R&D Quality Assurance
Job Type:  Direct Employee
Team:  Quality
Contract Type:  Permanent
Location: 

Stockholm or Anywhere in Europ, SE

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.

We are committed to embrace diversity, inclusion and equal opportunities. 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

To support the Corporate PV QA Unit, in order to ensure the compliance of the Global PV Quality System  with applicable regulatory requirements and company quality standard.

Please Note: Location can be flexible 

Main Responsibilities

•    To review of the Corporate SOPs related to the PV Quality System to ensure harmonization and compliance with current regulations and applicable company quality standards
•    To write SOPs/WIs related to the PV Quality System
•    To manage PV deviations
•    To monitor the CAPA Plan implementation
•    To ensure rapid communication of QA issues to the relevant stakeholders.
•    To support in the compliance monitoring, including metrics collection.
•    To cooperate in the planning and execution of the Corporate PV Quality System trainings to Global and Affiliates Personnel
•    To support the IT department in the validation activities related to the pharmacovigilance computerized system
•    To support the Quality Review of the PSMF

Experience Required

At least 1 year experience in Pharmacovigilance or QA Pharmacovigilance

Education

Scientific degree, Pharmacist or Life Sciences

Languages

English deep knowledge, both oral and written

Technical Skills

Comprehensive knowledge of PV regulations and PV Quality management system principles

Use of common computer tools (e.g. Office)

Soft Skills

  • Attention to details
  • Continuous learning
  • Planning and organizational skills
  • Problem solving
  • Quality 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.

Discover all our opportunities