Validation & Compliance Specialist

Validation & Engineering Group; Guaynabo (PR); On-site; Full time

Job summary

A leading services supplier in validation is seeking qualified candidates for a role involving periodic reviews of equipment and temperature chambers, computerized system assessments, and reporting Annual Product Reviews. The ideal candidate should hold a BS in Science or Engineering and be ready to engage in Deviation and CAPA Ownership, as well as Quality Risk Assessments. This position is based in Guaynabo, Puerto Rico.

Responsibilities

• Periodic review of equipment.
• Periodic review of controlled temperature chambers.
• Periodic review of computerized systems.
• Annual Product Review reporting for commercial equipment.
• Deviation and CAPA Ownership related to Validation Maintenance.
• Validation Change Control assessments.
• Lead and facilitate Quality Risk Assessments.

Education

BS in Science or Engineering

Job description

Validation & Engineering Group,Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical,and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.

Job Description

• Periodic review of equipment.
• Periodic review of controlled temperature chambers.
• Periodic review of computerized system – Includes assessing systems to be enrolled in computerized system periodic review.
• Annual Product Review (systems list) reporting for commercial equipment.
• Deviation and CAPA Ownership and Support related to Validation Maintenance issues.
• Validation Change Control assessments.
• Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES).
• Performance tracking and metric reporting.

Qualifications

BS in Science or Engineering

Additional Information

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

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