The role is responsible for ensuring Norgine's IT Quality Management System, validation documentation, processes and systems meet applicable GxP and regulatory requirements. You will also support the continued development and improvement of the Global IT validation strategy and approach.,
- Execute and support risk-based Computer Systems Validation (CSV) activities throughout the lifecycle of GxP systems, from implementation and enhancement through maintenance, review and retirement.
- Develop, review and maintain validation documentation to ensure systems remain in a validated state.
- Support validation governance, including validation planning, Validation Master Plan maintenance, change assessments and validation standards.
- Coordinate validation testing, document outcomes and support the assessment and resolution of identified issues and risks.
- Partner with Business, Quality, IT and project teams to ensure validation requirements are defined and maintained throughout system changes and projects.
- Support internal audits, regulatory inspections, periodic reviews and compliance assessments.
- Provide guidance on CSV, data integrity and applicable regulatory requirements, while contributing to continuous improvement of CSV frameworks, methodologies and processes., At Norgine, you'll be part of an inclusive environment where diverse perspectives are valued. You'll have the opportunity to grow your career while making a meaningful impact on patients' lives.
Bring your curiosity, creativity and drive. However you work best, you'll find the support to succeed.
Ways of Thinking & Working to Support Your Growth
- Curious, reflective and open to different perspectives
- Collaborative across teams, functions and geographies
- Comfortable working independently and asking questions when needed
Demonstrable experience in Computer Systems Validation within a GxP-regulated environment. - Good understanding of business requirements, high-level solutions and IT infrastructure alongside CSV experience.
- Strong understanding of relevant regulatory requirements, including EudraLex Annex 11 and FDA 21 CFR Part 11.
- Good understanding of data integrity requirements within regulated environments.
- Experience developing, reviewing and maintaining validation documentation and records.
- Experience with risk-based validation, quality systems, change management and compliance risk management.
- Knowledge of quality assurance methodologies, requirements creation and verification, review and reporting, and data management techniques.
- Ability to work collaboratively across Quality, IT, business and project teams, providing guidance and subject matter expertise.
- Familiarity with multiple system types such as ERP/BI, LIMS and HRIS would be beneficial.
We're looking for someone who demonstrates accountability, sound decision-making and integrity, with the confidence to address difficult issues, manage complexity and continuously improve how work is delivered. These behaviours support Norgine's core values of Drive, Dare and Develop, including taking ownership, challenging constructively, seeking new ideas, collaborating effectively and valuing different perspectives.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine, offering a fully-rounded experience where you can make a difference, continue developing and be part of a supportive community. Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.
CSV Analyst - 12 Months FTC employer: Norgine B.V.
Norgine B.V. is an excellent employer that fosters a collaborative and innovative work culture, where employees are empowered to make a meaningful impact on product quality and compliance. Located in a dynamic environment, the company offers robust growth opportunities through professional development and training, ensuring that team members can advance their careers while contributing to the success of the Global Quality Team. With a strong commitment to employee well-being and a focus on teamwork, Norgine provides a rewarding workplace for those passionate about quality assurance in the pharmaceutical industry.
