Validation Specialist
Omni Inclusive
Validation Specialist (Life Sciences)
- Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
- Translate complex scientific and technical concepts into clear, concise documentation.
- Collaborate with SMEs to gather and verify technical information.
- Ensure documentation complies with industry standards (GxP, ISO, ICH).
- Manage document lifecycle using electronic document management systems (EDMS).
- Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
- Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
- Conduct risk assessments and support change control processes.
- Review and approve validation documentation and reports.
Vacancy posted 3 days ago
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