Computer Systems Validation Specialist
Vor 5 Tagen
Job Summary
LS Solutions is seeking a highly experienced Computer Systems Validation Specialist to join our team. As a CSV Expert, you will be responsible for ensuring the compliance of computer systems throughout the software development lifecycle, validation, maintenance, and decommissioning.
Key Responsibilities
- Lead CSV approaches for individual projects and provide technical leadership as required to project implementation teams or IT staff maintaining GxP applications.
- Develop and build compliance frameworks and dashboards to proactively monitor compliance and act as required to assure compliance.
- Own and lead the CSV Centre of Excellence (CoE) and Community of Practice (CoP), delivering and maintaining a world-class QMS for CSV & Data Integrity.
- Provide CSV SME leadership and educate and mentor IT staff with minimal GxP knowledge and experience.
Requirements
- 10+ years of hands-on CSV experience with a strong working knowledge of data integrity requirements, controls, execution, evidence, and reporting.
- Recent Biopharmaceutical Industry Experience and FDA/EMA Inspection Readiness.
- Proven technical leadership skills and ability to communicate effectively with cross-functional teams.
What We Offer
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive compensation package.
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