
System Validation Specialist
13 hours ago
About our client:
Our client is a leading software giant in India, with a global workforce and presence across the globe.
· JobTitle: Validation Engineer
· Location: HYderabad/Bangalore
· Experience: 5 - 10 yrs
· NoticePeriod:- Immediate - 30 days
Mandatory Skills:
- Bachelor's degree in related field or equivalent required.
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
Benefits:
- Ability to develop clear, concise, and timely oral and written reports.
- Excellent written and oral communication skills.
- Ability to work on complex projects with general direction and minimal guidance.
- Ability to handle multiple projects and meet deadlines.
Requirements:
- Bachelor's degree in related field or equivalent required.
- Preferred Skills and Experience:
- Hands-on experience with Microsoft word, Excel, PowerPoint & Visio.
- Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.
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