Pharma IT Systems Analyst – CSV/GxP
Compunnel Inc.
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Job summary
Compunnel Inc. is seeking an IT Business System Analyst I to support local IT applications and act as a liaison between IT and business operations within a pharmaceutical environment.
The role will assist in application operations, business analysis, CSV, GxP compliance, technical documentation, testing, and coordination with stakeholders and vendors. The candidate will provide IT application support, analyze business needs, support CSV and GxP activities, and contribute to test planning and
Qualifications
- 1+ years of IT application support; 3+ years preferred.
- Experience with business analysis and requirements gathering.
- Experience with CSV and/or GxP environments.
- Strong technical documentation skills.
- Experience working with business stakeholders and vendors.
- Knowledge of SDLC, validation methodologies, and business analysis practices.
- Knowledge of 21 CFR Part 11 and GxP guidelines.
- Spanish language skills are a plus.
- Pharmaceutical, clinical research, R&D, or other regulated-industry experience is preferred.
Responsibilities
- Provide IT application support and troubleshoot system-related issues.
- Work with business users and IT teams to understand business needs and requirements.
- Analyze business processes and translate requirements into system specifications.
- Support Computer System Validation (CSV) and GxP-related activities.
- Develop, coordinate, and support test plans and SDLC testing.
- Prepare technical, validation, and business documentation.
- Support system configurations, integrations, and interfaces with instruments and other systems.
- Coordinate project activities, timelines, and status updates.
- Collaborate with internal IT teams, business stakeholders, and external vendors.
- Track and resolve technical issues and provide ongoing end-user support.
- Ensure systems and processes align with applicable quality and regulatory requirements.
Skills
Education
Tools
Job description
Compunnel Inc. is seeking an IT Business System Analyst I to support local IT applications and act as a liaison between IT and business operations within a pharmaceutical environment.
The role will assist in application operations, business analysis, CSV, GxP compliance, technical documentation, testing, and coordination with stakeholders and vendors. The candidate will provide IT application support, analyze business needs, support CSV and GxP activities, and contribute to test planning and
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