
Senior Validation Specialist
3 days ago
We are seeking a skilled Validation Professional to join our team.
Mandatory Requirements:- 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.
- Excellent written and oral communication skills.
- Able to develop clear and concise reports.
- Ability to work effectively in a team environment.
About the Role:
This is an excellent opportunity for a Validation Professional looking to advance their career in a dynamic and growth-oriented organization.
The successful candidate will possess strong technical skills, excellent communication skills, and the ability to work effectively in a team environment.
Why Choose Us?
Our organization offers a collaborative and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
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