
Senior Validation Specialist
6 days ago
A system validation engineer is needed to ensure the quality and integrity of our computer systems.
This role involves hands-on experience in Computer System Validation with a focus on GxP system, process validation, and equipment validation.
The ideal candidate will have a strong understanding of FDA Regulated manufacturing processes and cGMP concepts. They should also be familiar with EDMS (Electronic Document Management system) and Test Management tools.
In addition to technical skills, the successful candidate will possess excellent written and oral communication skills, with the ability to develop clear, concise reports.
Required Skills and Qualifications- Bachelor's degree in a related field or equivalent.
- Hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry for at least 5 years.
- Knowledge of FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Strong analytical and problem-solving skills with attention to detail.
This is a full-time permanent position offering a competitive salary and benefits package.
The role requires immediate joiners and offers a chance to work on complex projects with general direction and minimal guidance.
The company values versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
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