Junior Computer Systems Validation Analyst - Dreux, France - Norgine

Norgine

Entreprise vérifiée

Dreux, France

il y a 3 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Do you have an interest in Quality and Compliance?

Do you have a Degree and at least 3 years experience working in Quality Validation department in pharma/medical device industry?

Would you like to explore and develop a career in Computer Systems Validation?

If so this is an opportunity for a development role where you will be given full support to develop yours skills to become a fully competent CSV analyst.

Sound interesting? Then read on

In this role, you will be responsible for Supporting the CSV Team in delivering the Global IT validation strategy and approach taking into account the relevant GxP requirements, act as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management and the project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.

Ultimately, at Norgine, we look for the following skills and experience:

Bachelor's degree preferred
3 years experience of working within Quality/Validation teams in pharma/medical device industry.
Good understanding of Quality Management Systems
Good understanding of business process
Knowledge of the data integrity implications of the regulated environment
Good written and oral communication skills
Competent user of Microsoft Office

Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets.

We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure.

This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.