
Senior Validation Specialist
4 days ago
About Our Role:
We are seeking a highly skilled and experienced Validation Engineer to join our team.
- Mandatory Skills:
- Proven experience in computer system validation, quality compliance and GxP systems within FDA-regulated industries.
- Knowledge of cGMP concepts and regulations including QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 9001 Standards and FDA guidance on CSV to CSA transition.
- Strong understanding of FDA-regulated manufacturing processes, process validation, equipment validation and GMPs.
- Hands-on experience with electronic document management systems (EDMS) and test management tools.
- Ability to work effectively with complex projects, prioritize tasks and meet deadlines.
Key Responsibilities:
- Develop clear, concise and timely reports for various stakeholders.
- Work independently on complex projects with minimal supervision.
- Manage multiple projects simultaneously and ensure timely delivery.
- Utilize prioritization and workflow management skills to achieve project goals.
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