Senior CSV Specialist
Senior CSV Specialist
Posted on :
02-01-2025
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1 Vacancy
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Job Description
We are looking for a Senior CSV Specialist with experience in Veeva CRM Validation to handle system validation tasks including requirements analysis OQ scripting and customer interactions.
Key Responsibilities:
- Lead and execute Computer System Validation (CSV) activities ensuring adherence to industry regulations and company standards.
- Perform Requirements Analysis to gather define and document system validation needs.
- Develop review and execute Operational Qualification (OQ) scripts to validate system performance.
- Conduct comprehensive validation for Veeva CRM systems ensuring compliance with GxP standards and other regulatory guidelines.
- Provide clientfacing expertise including effective communication documentation review and addressing client queries.
- Collaborate with crossfunctional teams to manage validation deliverables and timelines.
- Stay updated with industry best practices trends and emerging validation methodologies.
Requirements
Benefits
5-7 years of experience in CSV in regulated industries (pharma, life sciences, etc.) Hands-on experience with Veeva CRM Validation Strong knowledge of Requirements Analysis and OQ scripting Good communication skills for customer interactions Familiarity with regulatory standards like GxP and 21 CFR Part 11
Education
Required: Bachelor s degree in one of the following fields: Computer Science Information Technology Engineering (Electrical, Software, or similar) Life Sciences (Pharmacy, Biotechnology, etc.) Preferred: Master s degree in relevant fields (e.g., IT, Life Sciences, or Engineering). Certifications in Computer System Validation (CSV), GxP Compliance, or related areas.
Employment Type
Full Time
Key Skills
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