Roche
Intern IT Validation Specialist (Recent Graduate)
This job is now closed
Job Description
- Req#: 202410-125094
Learning and Development: Engage in structured training programs to gain knowledge and expertise in validation approaches and documentation review for GxP computerized systems.
Documentation Support: Assist in the development and review of validation plans, test plans, and reports while adhering to Roche CSV SOPs and regulatory guidance.
Testing Assistance: Support the verification of testing plans, activities, and deliverables. Provide input on test-related deviations and corrective actions.
Investigation Participation: Collaborate in root cause analysis for deviations and contribute to defining corrective and preventive actions.
Audit Preparation: Learn to act as a support resource during system audit/inspection preparation and execution.
System Maintenance: Assist in maintaining the validated state of systems to ensure they are audit and inspection ready.
Periodic Reviews: Participate in system periodic reviews according to company procedures.
Mindset: Strong willingness to learn and grow within the field of IT & Software Validation and Testing; enthusiastic about continuous professional development.
Regulatory Awareness: Basic understanding (a plus) or strong willingness to learn about FDA regulations/guidance (e.g., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).
Risk Understanding: Awareness of system and data risk assessment concepts is a plus
Agile Methodology: Interest or basic understanding of Agile Methodology (Frameworks such as SAFe, Scrum) is a plus.
Collaboration: Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals.
Communication: Effective verbal and written communication skills; proficiency in English is mandatory.
Soft Skills: Assertiveness and ability to work with diverse personalities and cultures; adaptable and open to feedback.
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
Junior IT Validation Professional [Recent Graduate]
Purpose of the role
At Roche, compliance is our license to operate, and we are committed to delivering high-quality products. Every contribution you make will impact patients, as patient safety is at the forefront of everything we do. As a Junior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. You will be responsible for the evaluation, design, development, and approval of validation plans, protocols, and reports for computerized systems across various domains and product lines.
Main responsibilities:
How would your day-to-day look like?
Your daily journey as a Junior IT Validation will involve a blend of teamwork, learning, and technical challenges. You'll start your day by engaging with the product team to assess the validation and compliance requirements of a system and ensure its validated state is kept. You will learn how to assess the compliance health of a system and learn how to balance compliance and efficiency. Your creative input will be valued as you help us streamline our validation and testing processes through automation, AI, lean mindset, etc. — making our work smarter, not harder.
At the end of the day, your contributions will ensure that both our team and our customers are set up for success. You'll have the full support of your colleagues and leaders, who are just as dedicated to your growth.
W ho are you?
We are looking for a recent graduate no more than 3 years- with a Bachelor's or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field, with a passion for IT & Software Validation and a keen interest in working within the pharmaceutical industry, and possess the following:
What Do We Offer?
We offer a dynamic and collaborative work environment where you will have the opportunity to learn and grow in the field of Software Validation & Testing, Healthcare regulations, etc. You will be part of a team that is dedicated to driving innovation and excellence in healthcare technology. We provide a competitive salary, a comprehensive benefits package, and opportunities for professional development and advancement.
If you are interested in making a significant impact on patient safety and product quality, apply today!
This opportunity is part of the START TECH program, you can find more information about the program in the following link:https://careers.roche.com/global/en/start-tech-program-spain
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
About the company
606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.
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