
System Validation Professional
2 weeks ago
About Us:
We are a technology company based in India, providing IT services to our clients. Our services include cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics, and other technologies.
- Experience: 5-10 Yrs
- Employment Type: Full time
- Notice Period: Immediate joiner - 30Days (Notice period)
Mandatory Skills:
- 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.
- Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in EDMS & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- 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.
- Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
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