Validation Engineer
2 weeks ago
Our client is an Indian multinational technology company based in Bengaluru. It provides information technology, consulting and business process services, and is one of India's Big Six IT services companies. Services include cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics, and other technologies.
- Job Title : Validation Engineer
- Job Locations : Bangalore/Hyderabad
- Experience : 5-10 Yrs
- Employment Type : Full time
- Notice Period : Immediate joiner - 30Days (Notice period)
Mandatory Skills:
- 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.
- 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 (Electronic Document Management system) & 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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