USA_Developer

Varite Inc

Wilmington, DE, United States

8 days ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Compensation

$110,302.0 - $118,352.0

Working hours

Regular working hours

Job source

www.thejobnetwork.com

Tech stack

Audit Trail System Testing VeevaVault GXP

Job description

21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes Authoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals

Requirements

Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor’s in Pharmacy Experience: Over 8 years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills, Skills:CategoryNameRequiredImportanceExperienceSkillCategoryTest1_MNLife Sciences : Computer System ValidationYes1>7 years

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