IT-QA Senior Validation Engineer

Company:  Katalyst Healthcares & Life Sciences
Location: Boston
Closing Date: 19/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:

Computer system validation, Data integrity.

Medical device 510K, Predicate rules, ECTD,21 CFR Part 11, 210, 211, 312, 314, 820 GXP,

GMP, GDP, GLP, CAPA.

Change control, Risk assessment, Data base, Trail master file, EPIC system validation.

Enrollment 834, Claims 837, Qualitative & Quantitative Analysis.

HL7, HIPPA, SOP, SQL, HTML, XML, EDI, Silk, Client Quality Center, Jira Confluence, Microsoft TFSLIMS.

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