
Systems Validation Specialist
23 hours ago
We are seeking a highly skilled Systems Validation Specialist to join our team. In this role, you will be responsible for ensuring the validation of computer systems in a FDA regulated environment.
- A Bachelor's degree in a related field is required.
- At least 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
The ideal candidate will have knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards. They should also have hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
In addition to technical skills, the successful candidate will possess excellent written and oral communication skills, as well as the ability to work on complex projects with general direction and minimal guidance.
Key Responsibilities:- Develop clear, concise, and timely reports.
- Manage priorities and workflow.
- Work within constantly changing priorities with enthusiasm.
- Bachelor's degree in a related field.
- Strong knowledge of FDA Regulated manufacturing processes.
- Knowledge of GMPs.
- Hands-on experience in EDMS (Electronic Document Management system).
- Test Management tools.
This is an exciting opportunity for someone who is passionate about systems validation and quality compliance. If you are a motivated individual with excellent communication skills and a strong background in systems validation, we encourage you to apply.
About Us:We are a global company that delivers end-to-end technology, consulting, and business process services to clients across the globe. We have a presence in 60+ countries and are a publicly traded company listed on NSE & BSE (India) and NYSE (USA).
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