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About the Role
Validation Specialist to support validation activities within a regulated Medical Devices manufacturing environment. The ideal candidate will have strong knowledge of the Validation Life Cycle and hands-on experience executing validation deliverables in compliance with FDA and global regulatory requirements.
Key Responsibilities:
- Execute and support validation protocols and reports including IQ, OQ, PQ for equipment, utilities, processes, and/or computer systems.
- Ensure all validation activities comply with applicable regulations and site quality standards.
- Lead and/or support the full Validation Life Cycle (planning, risk assessment, execution, and closure).
- Develop and review validation documentation including Validation Plans, URS, FRS, RTM, protocols, and summary reports.
- Participate in risk assessments (e...
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