Validation Specialist

Caguas, PR
Permanente
Tiempo completo

Hace 5 días

Company DescriptionQRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.Log on now to our website / to learn more about our services and solutions!Job DescriptionValidation Specialist with hands-on experience in executing validation and qualification activities across diverse areas, including:Process
Packaging
Manufacturing
Laboratory
Computer System Validation (CSV)
Software
Facilities and Utilities
Site Acceptance Testing (SAT) & Factory Acceptance Testing (FAT)
Commissioning and Decommissioning of Systems and EquipmentCore Competencies:Skilled in drafting protocols, technical reports, and validation documentation in alignment with regulatory and industry standards (e.g., FDA, GMP).
Proven ability to collaborate effectively with cross-functional teams—including Engineering, Quality, and Production—to ensure compliance, optimize processes, and support operational readiness.QualificationsBachelor Degree in Science, or related field
Minimum 5 years of experience in validations within a regulated industry.
In-depth knowledge of GMP, FDA, and international standards.
Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning.
Ability to write clear and precise technical documentation.
Excellent communication and teamwork skills.
Bilingual (English/Spanish - understand, write and speak).Additional InformationAll your information will be kept confidential according to EEO guidelines.

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