What are the responsibilities and job description for the CSV CONSULTANT position at United Pharma Technologies Inc?
Role: Computerized Systems Periodic Review Consultant
Location: La Verne, CA (100% Onsite)
Job Summary
We are seeking an experienced consultant to support periodic reviews of GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will be responsible for evaluating system documentation, assessing compliance, and preparing comprehensive periodic review reports.
Key Responsibilities
- Conduct periodic reviews of GxP computerized systems.
- Prepare and complete detailed review reports using established templates.
- Analyze system lifecycle and validation documentation.
- Gather and verify information from quality and maintenance systems.
- Ensure compliance with internal procedures and regulatory requirements.
- Maintain accurate, audit-ready documentation.
- Collaborate with cross-functional teams to support review activities.
Required Qualifications
- Hands-on experience performing periodic reviews of GxP computerized systems.
- Strong knowledge of Computer System Validation (CSV) and regulated documentation practices.
- Experience with Veeva, ValGenesis, and IBM Maximo.
- Ability to review technical documentation and develop compliance-focused reports.
- Excellent analytical, organizational, and technical writing skills.
- Pharmaceutical, biotechnology, or life sciences industry experience preferred.