GXP Systems Specialist
New
F
Fresh PrintsBiotech Pharmaceuticals
India and the Philippines (Fully Remote), 10:00 AM to 6:00 PM GMT (Monday – Thursday)ContractMiddle
Salary not disclosed
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Job Details
- Required Skills
- GCPSharePoint
Requirements
- Strong background in Computer System Validation (CSV) in biotech, pharma, or life sciences.
- System administrator-level experience with Box, Ignite, and SharePoint.
- Deep understanding of GAMP guidelines and GCP regulations.
- Experience transferring data from Electronic Trial Master Files (eTMFs) is a strong plus.
- Prior hands-on experience or familiarity with ACE Software (by PSC) is highly desirable.
- Ability to perform in a 12-week contract sprint with minimal ramp-up time.
- Strong technical communication skills for cross-functional alignment.
Responsibilities
- Manage and execute a short-term, Box-to-Box data transfer project.
- Maintain system administrator responsibilities for SharePoint, Ignite, and Box.
- Manage and execute the full validation lifecycle for clinical trial systems.
- Ensure technical compliance with GAMP guidelines and GCP regulations.
- Provide auxiliary support and optimization for ACE Software (by PSC) eQMS.
- Report to the Senior Director, QMS and Clinical QA, and partner with IT and project leadership.
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