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Laboratory Equipment Validation Specialist
The Laboratory Equipment Validation Specialist is responsible for the validation and lifecycle management of laboratory equipment. This role ensures compliance with cGMP regulations through the planning, execution, and documentation of validation activities for analytical instruments, with a strong focus on UPLC systems and densitometer. The specialist will support laboratory operations by maintaining validated states and ensuring data integrity and regulatory compliance.
Key Responsibilities
Plan, execute, and document laboratory equipment validation activities.
Develop, review, and approve validation protocols, reports, risk assessments, and traceability matrices.
Perform validation of analytical laboratory instruments, including UPLC systems and densitometer, as well as other laboratory equipment as assigned.
Ensure compliance with cGMP.
Requisitos: Requirements: Requirements Bachelor in Science, or a related scientific discipline. Minimum of three (3) years of relevant experience in a regulated laboratory in pharmaceutical environment. Demonstrated hands-on experience in the validation of UPLC systems and densitometer. Strong knowledge of equipment qualification and validation requirements, data integrity principles, and applicable regulatory expectations. Bilingual in English and Spanish (written and spoken). Excellent technical writing, organizational, and communication skills. Requiere Mucha Experiencia Requires Expert
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QRC GROUP LLC
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