Junior Computer Systems Validation Analyst
Norgine, France
Job 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.
- Awareness and active interest in regulatory requirements and how they might apply to computer systems.
- 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
If this resonates and is what you might be searching for, apply now!
A recent acquisition by Goldman-Sachs, Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 24 million patients around the world in 2021 and generated 505 million in net product sales, a growth of 10% over 2020.
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.
In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.