QRC Group, LLC

C&Q Specialist

QRC Group, LLC  •  Vega Baja, PR (Onsite)  •  1 day ago
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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.

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

    .


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)
  • QRC Group, LLC

    About QRC Group, LLC

    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

    Industry
    HR & Recruiting
    Company Size
    11-50 employees
    Headquarters
    Caguas, PR
    Year Founded
    2005
    Social Media