
System Validation Expert
3 days ago
About us:
We are a leading provider of technology, consulting, and business process services. Our global workforce of over 240,000 employees delivers end-to-end solutions to clients across the globe, with presence in more than 60 countries.
· Job Title: Validation Specialist
· Location: Hyderabad/Bangalore
· Experience: 5-10 years
· Notice Period: Immediate - 30 days
Mandatory Skills and Qualifications:
· Bachelor's degree in a related field or equivalent.
· 5-8 years of hands-on experience in computer system validation/quality compliance in a FDA-regulated industry (medical device/pharma/life sciences) with a focus on GxP systems.
· 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:
· Develop clear, concise, and timely oral and written reports.
· Ability to work on complex projects with general direction and minimal guidance.
· Ability to handle multiple projects and meet deadlines.
Other Requirements:
· Microsoft Word, Excel, PowerPoint & Visio skills.
· Hands-on experience with EDMS (Electronic Document Management System) & Test Management tools.
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