Job Description
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.
Qualifications
- 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)
Additional Information
All your information will be kept confidential according to EEO guidelines.
Other open roles at QRC Group, Inc(6)
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Our services and solutions include: Process and Laboratory Investigation • Corrective and Preventive Action (CAPA) • Change Control • Training • Document Management Control • QA Laboratory • Methodology Transfer and Validation • Instrument Calibration • Validation and Training in Chromatographic Data Acquisition System • Cleaning Validation • Automation Engineering • Quality Systems
Key team members
Gilbert González
Mayra Nales Alvarez
Zulma Sanchez
Diosdado Viera Hornedo
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