Systems Assurance Specialist
6 days ago
About People Prime Worldwide has evolved into a leading global technology consulting firm with a presence in 60+ countries and a workforce of 240,000 employees.
We partner with top software giants to deliver high-quality services.
Job Title: Validation Engineer
Key Responsibilities:- Develop clear, concise, and timely oral and written reports on projects.
- Work independently on complex projects with minimal guidance.
- Manage priorities and workflow with versatility and enthusiasm.
Required Skills and Experience:
- Bachelor's degree in a related field or equivalent.
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in FDA Regulated industries (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 manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in Electronic Document Management systems & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
Preferred Skills and Experience:
- Hands-on experience with Microsoft Office Suite.
- Hands-on experience with Electronic Document Management systems & Test Management tools.
- Experience: 5 - 10 yrs
- Notice Period: Immediate - 30 days
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