
CSV Compliance Specialist
3 days ago
Job Overview:
We are seeking a skilled CSV Specialist to join our team. The ideal candidate will have experience in computer system validation, with a strong understanding of GxP regulations and data integrity requirements.
Key Responsibilities:
- Validate computerized systems to ensure compliance with regulatory guidelines.
- Develop and maintain validation documentation, including risk assessments and impact analyses.
- Collaborate with cross-functional teams to ensure validation deliverables meet project timelines.
- Guide project teams on validation requirements and risk-based approaches.
- Evaluate data integrity across systems and processes.
Required Skills and Qualifications:
- 2-4 years of hands-on experience in computer system validation within pharmaceutical, biotech, or life-sciences industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
What We Offer:
- A dynamic work environment with opportunities for professional growth.
- The chance to collaborate with experienced professionals in the field.
- Competitive compensation and benefits package.
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