
Senior CSV Specialist
1 week ago
Job Summary: We are seeking a seasoned CSV Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the validation and compliance of our computerized systems.
">Key Responsibilities:
- Perform risk-based validation activities for GxP computerized systems, including planning, assessment, and documentation.
- Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines.
- Conduct periodic reviews and impact assessments for existing validated systems.
- Collaborate with cross-functional teams to ensure validation deliverables are met within timelines.
- Guide project teams on validation requirements and risk-based approaches.
- Ensure data integrity compliance across systems and processes.
Requirements:
- 2-4 years of 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 and collaborative work environment.
- Ongoing training and development opportunities.
- The chance to work on challenging projects and contribute to the success of our organization.
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