C&Q Specialist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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We are seeking a C&Q Specialist responsible for executing and documenting Installation Qualification (IQ) and Operational Qualification (OQ) activities.

Project Scope

The C&Q activities will support a capital upgrade project that includes:

• Removal and decommissioning of existing equipment, and installation of new equipment.
• Upgrade of the control system and safety architecture.
• Execution of functional and safety testing to confirm proper operation following the upgrade.
• CAPA
• Data Integrity

Key Responsibilities

• Provide on-site validation support during shutdown and installation activities.
• Execute IQ and OQ protocols and associated components.

• Verify proper installation, configuration, and functionality

• Support and witness functional testing and integrated systems.
• Ensure equipment installation complies with approved drawings, specifications, and manufacturer recommendations.
• Document test results accurately and in compliance with regulated documentation practices.
• Identify, document, and support the resolution of deviations, discrepancies, and anomalies.
• Generate and complete validation reports and execution summaries.
• Collaborate with related teams during commissioning and qualification activities.
• Ensure all validation activities comply with applicable GxP, safety, and quality requirements.

• Bachelor’s degree or technical degree in Engineering, Science, or a related technical field or equivalent validation experience.
• Proven experience executing IQ/OQ or validation activities.
• Prior experience validating mechanical equipment is strongly preferred.
• Solid understanding of Commissioning & Qualification (C&Q) concepts.
• Technical Writing
• Bilingual (Spanish/English)(Write/Speak)

All your information will be kept confidential according to EEO guidelines.