Job Description
We are looking for a Computer Systems Validation (CSV) Specialist to play a key role in ensuring compliance with regulatory requirements and internal standards by leading validation efforts throughout the system lifecycle. This position requires strong collaboration across cross‑functional teams and a solid understanding of risk‑based validation methodologies.
Tasks & Responsibilities
- Ensure that all validation activities are properly planned and executed in accordance with validation strategies, GxP requirements, and applicable BI SOPs prior to system go‑live.
- Maintain the system’s validated state throughout its lifecycle.
- Collaborate closely with Quality Assurance (QA) on compliance‑related topics.
- Coordinate with System Owners, Process Owners, Business Process Owners, System Leads, Developers and other stakeholders.
- Ensure that all system‑specific SOPs and System Lifecycle (SLC) documentation are in place before s...
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