
System Validation Specialist
3 days ago
About Us:
We are seeking a highly skilled Validation Engineer to join our team.
Job Summary:
The Validation Engineer will be responsible for ensuring the accuracy and reliability of our systems and processes.
Responsibilities:
- Conduct thorough system validation and qualification activities
- Develop and implement effective quality control measures
- Collaborate with cross-functional teams to identify and mitigate risks
- Analyze data and create reports to inform business decisions
Requirements:
- Bachelor's degree in a related field or equivalent
- 5-8 years of experience in Computer System Validation/Quality Compliance
- Strong knowledge of FDA Regulated manufacturing processes and GxP system
- Experience with EDMS (Electronic Document Management system) & Test Management tools
Benefits:
- Competitive salary and benefits package
- Opportunity to work on complex projects with general direction and minimal guidance
- Ability to develop clear, concise, and timely oral and written reports
Preferred Skills:
- Hands-on experience with Microsoft word, Excel, PowerPoint & Visio
- Familiarity with FDA's recent guidance on transition of CSV to CSA
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