Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

7 years minimum

Working hours

Regular working hours

Job source

www.careerjet.com

Tech stack

Data Migration System Testing Iq/oq/pq Cloud Migration GXP

Job description

• Lead end-to-end CSV activities (inventory * assessment * remediation * disposition)
• Support business separation for large GxP systems
• Define & implement risk-based validation strategies
• Review & approve test plans, UAT scripts, validation documents
• Ensure compliance with regulatory & quality standards
• Provide guidance, escalation & leadership to validation teams
• Collaborate with global & remote teams

Requirements

• 7-10 years in CSV / Validation roles
• Experience in Pharma / Biotech / Medical Devices industry
• Proven experience in regulated environments (FDA/GxP)
• Strong expertise in CSV (Computer System Validation) in GxP environments
• Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
• Hands-on in Acquisitions / Divestitures / Business Separation projects
• Deep understanding of FDA regulations & GxP standards
• Experience with Risk-based validation approach
• Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
• Experience in UAT, Traceability Matrix & QA methodologies
• Ability to lead teams & manage multiple projects

Apply for this position

This job is hosted externally. Click below to view the full posting and apply.

Apply on www.careerjet.com

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