Senior Validation Specialist
6 days ago
We are seeking a skilled Validation Engineer to join our team.
The ideal candidate will have experience in computer system validation and quality compliance, with a focus on GxP systems. They will be responsible for ensuring that all computer systems meet regulatory requirements and industry standards.
This is an excellent opportunity for someone looking to take their career to the next level.
">- 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.
Key Responsibilities:
- Develop clear, concise, and timely oral and written reports.
- Manage priorities and workflow, and demonstrate versatility, flexibility, and a willingness to work within constantly changing priorities.
- Work on complex projects with general direction and minimal guidance.
- Handle multiple projects and meet deadlines.
Benefits:
As a member of our team, you can expect a competitive compensation package and opportunities for professional growth and development.
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