
Validation Systems Specialist
2 days ago
About this role:
Our team is seeking a skilled Validation Engineer to join our organization. The successful candidate will be responsible for ensuring the quality and integrity of our systems and processes.
Job Details
• Job Title: Validation Engineer
• Location: HYderabad/Bangalore
• Experience: 5 - 10 yrs
• Notice Period: Immediate - 30 days
Skill Requirements
We are looking for candidates with 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. Key skills include:
- 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.
Qualifications
We require a Bachelor's degree (B.S.) in a related field or equivalent. Preferred skills include hands-on experience with Microsoft word, Excel, PowerPoint & Visio.
Benefits
This role offers the opportunity to work on complex projects with general direction and minimal guidance. You will have the ability to develop clear, concise, and timely oral and written reports, as well as manage priorities and workflow.
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