Quality System Specialist
2 weeks ago
- Support global Quality Systems operations to ensure compliance with global SOPs and fit for intended use.
- Assist in governance, harmonization, and improvement of Quality System applications across sites.
- Collaborate with Site Process Owners and SMEs in workshops to gather and prioritize requirements.
- Manage change controls and documentation, ensuring systems remain in a validated state.
- Support validation activities, including authoring test scripts, executing tests, and discrepancy management.
- Provide customer support for system onboarding, training, and user documentation updates.
- Generate metrics, support system updates, and assess new features to improve Quality Systems.
- Maintain an understanding of US FDA, European regulatory requirements, and ICH guidelines.
Qualifications:
- Bachelor’s degree in computer/technical/quality/scientific discipline; 3-6 years of experience in pharma/healthcare.
- Proficiency in MS Word, Excel, and Quality System processes; knowledge of Veeva Vault, TrackWise, and ComplianceWire is a plus.
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