Computer System Validation Specialist
il y a 6 jours
**Job Description:**
We are seeking a highly skilled Computer System Validation (CSV) Engineer to oversee and execute validation activities for pharmaceutical packaging lines at Optimus Search.
The CSV Engineer will be responsible for ensuring compliance with regulatory requirements related to computerized systems. This role requires expertise in validation planning, documentation, execution, and risk assessment for packaging line equipment and automation systems.
Key Responsibilities:
- Validate computerized systems to ensure compliance with FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other regulatory requirements.
- Develop and execute validation plans, protocols, and reports for pharmaceutical packaging lines.
- Conduct risk assessments for packaging line equipment and automation systems.
- Collaborate with cross-functional teams to ensure seamless integration of validated systems.
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