We are seeking a skilled CSV Expert to support client projects in validating computerized systems within GMP-regulated environments.The role involves ensuring systems meet regulatory standards and industry best practices for compliance and data integrity.
Key Responsibilities
- Plan, execute, and document computer system validation activities
- Develop validation documentation
- Ensure compliance with regulatory requirements
- Support audits, data integrity reviews, and system qualification activities
- Collaborate with IT, QA, and business teams on system implementation and validation
- Identify risks and propose mitigation strategies for validated systems
- Provide technical guidance and mentorship where applicable
Qualifications
- Degree in Life Sciences, Engineering, IT, or related field
- Relevant experience in CSV within regulated industries
- Knowledge of GxP regulations, validation lifecycle, and data integrity principles
- Strong documentation, communication, and analytical skills
Only shortlisted candidates will be contacted. We appreciate your interest and look forward to reviewing your application.