
System Validation Specialist
5 days ago
About this role:
We are seeking a skilled Validation Engineer to join our team.
Job Title: Validation Engineer
Location: HYderabad/Bangalore
Experience: 5 - 10 yrs
Notice Period: Immediate - 30 days
Mandatory Skills and Qualifications:
- Bachelor's degree in related field or equivalent.
- 5-8 years of experience in Computer System Validation/Quality Compliance in FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
Key Responsibilities:
- 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.
Preferred Skills and Qualifications:
- Hands-on experience with Microsoft word, Excel, PowerPoint & Visio.
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