At a Glance
- Tasks: Ensure IT systems meet regulatory requirements and support validation processes.
- Company: Join Norgine, a leader in transforming healthcare with over a century of expertise.
- Benefits: Inclusive environment, career growth opportunities, and meaningful impact on patients' lives.
- Other info: Collaborative culture that values diverse perspectives and encourages continuous improvement.
- Why this job: Be part of a supportive community while developing your skills in a dynamic role.
- Qualifications: Experience in Computer Systems Validation within a GxP-regulated environment.
The predicted salary is between 29700 - 36300 £ per year.
Description
Want a 3D Career? Join Norgine.
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.
We have an exciting opportunity for a Computer Systems Validation Analyst to join Norgine.
The Role
The role is responsible for ensuring Norgine's IT Quality Management System, validation documentation, processes and systems meet applicable Gx P and regulatory requirements.
You will also support the continued development and improvement of the Global IT validation strategy and approach.
This is a 12-month fixed-term contract (FTC) role
Requirements
Key Responsibilities
- Execute and support risk-based Computer Systems Validation (CSV) activities throughout the lifecycle of Gx P 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.
Skills and Experience
- Demonstrable experience in Computer Systems Validation within a Gx P-regulated environment.
- Good understanding of business requirements, high-level solutions and IT infrastructure alongside CSV experience.
- Strong understanding of relevant regulatory requirements, including Eudra Lex 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.
This job advert summarises key responsibilities and is not exhaustive. Norgine may adjust responsibilities as needed.
Why Join Us?
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
Benefits
Apply via Linked In or through our careers page.
We are committed to building an inclusive workplace and welcome applications from all backgrounds.
Our benefits may vary by location.
Please liaise with the Norgine TA representative to obtain more information.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.
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Every advert is reviewed and approved by our recruitment team before publication to ensure it accurately reflects the role and our organisation.
CSV Analyst - 12 Months FTC in Hengoed employer: Norgine
Norgine is an excellent employer that prioritises quality and patient safety, fostering a collaborative work culture where you can thrive alongside dedicated professionals. With a strong focus on employee growth, you will have access to continuous improvement initiatives and the opportunity to engage in meaningful projects that directly impact healthcare. Located in a dynamic environment, Norgine offers a supportive atmosphere that values compliance and innovation, making it an ideal place for those looking to make a difference in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land CSV Analyst - 12 Months FTC in Hengoed
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
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Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Norgine.
We think you need these skills to ace CSV Analyst - 12 Months FTC in Hengoed
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Norgine.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Norgine. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Norgine
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Norgine.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Norgine achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
