Senior Validation Specialist
8 hours ago
Key Responsibilities:
As a Senior Validation Specialist at Diverse Lynx LLC, you will be responsible for ensuring compliance with 21 CFR part 11, ALCOA, and GxP regulations. You will have hands-on experience with MES Validation, FTPS, PMX, and a strong understanding of GDPR and SOX regulations.
Technical Requirements:
- Knowledge of IO, OQ, and PQ testing
- Experience with Agile framework and testing tools like Client ALM, JIRA, qTest, and VERAS
- Understanding of Pharma concepts, CSV end-to-end lifecycle, and GAMP 5
Additional Requirements:
- Awareness of HIPAA and SOX Compliance
- Strong understanding of Traceability Matrix and Data Migration projects
- Ability to author and review project deliverables
About Diverse Lynx LLC:
Diverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company. All qualified applicants will receive due consideration for employment without any discrimination.
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