
Software Validation Specialist
2 days ago
We are seeking a skilled Software Validation Specialist to ensure our systems meet the highest standards of quality and compliance.
Mandatory Skills and Qualifications:- Bachelor's degree in a relevant field or equivalent
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems
- Fundamental knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards
- Strong knowledge of regulated manufacturing processes, process validation, computer and equipment validation, and Good Manufacturing Practices (GMPs)
- Hands-on experience in Electronic Document Management Systems (EDMS) & Test Management tools
- Hands-on experience with Microsoft Office suite
- Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools
As a key member of our quality assurance team, you will play a crucial role in ensuring our systems are reliable, efficient, and compliant with regulatory requirements.
The ideal candidate will have a strong foundation in software validation principles, excellent analytical skills, and the ability to work collaboratively as part of a dynamic team.
You will be responsible for conducting thorough risk assessments, developing and implementing effective validation strategies, and maintaining accurate records of testing and validation activities.
In addition, you will contribute to the development and maintenance of quality management systems, including documentation, training programs, and performance metrics.
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