Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.
At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.
Our Values include:
- Resilient Growth Mindset
- Executional Excellence
- Courageous Leadership
- Inclusive Collaboration
We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.
IT SW Validation Analyst
Job Summary:
The IT Software Validation Analyst ensures that all IT systems and software used by Ascensia Diabetes Care meet regulatory requirements and internal quality standards, contributing to the safety and efficacy of our diabetes care products.
Job Responsibilities:
- Support Ascensia IT Software Quality initiatives to simplify and standardize SDLC and software validation policies, procedures, and processes for computerized systems.
- Implement new or redesigned software validation programs and establish processes for maintaining existing validation documentation and remediating legacy systems.
- Review and approve internal and vendor software development and testing documentation. Conduct audits of software vendors as required to ensure compliance with quality and regulatory standards.
- Apply a risk-based approach to validation strategies and evaluate change request assessments to maintain compliance and minimize risk.
- Develop and deliver SDLC and Computer System Validation (CSV) training programs for IT and Operations teams to ensure consistent understanding and application of processes.
- Strong knowledge of computer system validation principles and regulatory compliance (e.g., FDA, ISO standards).
Qualifications and Experience :
- Minimum 5 years of industry experience working in medical device and/or pharmaceutical manufacturing, with a degree in Computer Science, Life Science, or software engineering. Preferred validation experience.
- Certified Software Quality Engineer ( CSQE) certification from ASQ preferred.
- Excellent understanding and application of principles, concepts and practices of Software validation methods, ISPE/GAMP 5, QSR/ISO regulations.
- Experience developing validation policies/ procedures/ guidance.
- Excellent organizational, interpersonal, written, and analytical, and oral communication skills required.
- SalesForce, ServiceNow, NetSuite and Sharepoint experience is a plus
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.