System Validation Expert

3 days ago


Malappuram, Kerala, India beBeeValidation Full time ₹ 15,57,500 - ₹ 20,95,000

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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