Validation Specialist
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Full Time
- Profesionales Profesional / (Profesionales - Otros) (Professionals - Others)
- Wanda Alvarez Colón Liz Rivera López
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Cidra
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Validation Specialist with a strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports).
Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment.
Updating and defining Standard Operating Procedures (SOPs).
Familiarized with Gage R&R methodology preferable.
Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.
Requisitos:
Requirements:
Bachelor in Science Experience in FDA regulated industry 5 years of experience performing validation lifecycle activities Technical writing skills Read, write, speak and understand English and Spanish
Requiere Mucha Experiencia Requires Expert
Requisitos:
Requirements:
Bachelor in Science Experience in FDA regulated industry 5 years of experience performing validation lifecycle activities Technical writing skills Read, write, speak and understand English and Spanish
Requiere Mucha Experiencia Requires Expert
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