
Software System Validation Specialist
1 day ago
Our organization seeks a highly experienced computer system validation expert to fill this critical role.
- Bachelor's degree in a related field or equivalent.
- 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA-regulated industry, with a focus on GxP systems.
This position is full-time and permanent. Key Responsibilities:
- Knowledge of fundamental cGMP concepts and FDA/EMA regulations.
- Familiarity with FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in EDMS and Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- Ability to develop clear, concise, and timely reports, as well as excellent written and oral communication skills.
The ideal candidate will have strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.
This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our organization.
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