IT Validation Analyst
Ascensia Diabetes Care
Posted
last week
Thane, Maharashtra, India
Onsite
INR 60K
Mid Level
Full Time
Sema Summary
The IT Software Validation Analyst ensures compliance of IT systems and software with regulatory requirements and internal quality standards. This role is essential for maintaining the safety and efficacy of diabetes care products.
About Company
Ascensia Diabetes Care is dedicated to improving the lives of individuals with diabetes through innovative solutions and is committed to delivering quality tools and support for diabetes management.
Core Requirements
- Degree in Computer Science, Life Science, or software engineering.
- Minimum 5 years of experience in medical device or pharmaceutical manufacturing.
- Certified Software Quality Engineer (CSQE) preferred.
- Strong knowledge of software validation principles.
- Experience developing validation policies and procedures.
Responsibilities
- Support IT Software Quality initiatives.
- Implement software validation programs.
- Review and approve software development documentation.
- Conduct audits of software vendors.
- Apply risk-based approaches to validation strategies.
- Develop and deliver training programs on SDLC and CSV.
- Maintain compliance and minimize risk.
Must Have skills
Job Keywords
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