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    Validation Lead - Jersey City, United States - RxCloud

    RxCloud
    RxCloud Jersey City, United States

    3 weeks ago

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    Description
    Job Description
    Job: Validation Lead (CSV, Clinical Systems)

    Location:NJ/PA(Hybrid)

    Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience

    Roles and Responsibilities:

    We are looking for a pure validation resource
    • 8 + years Experience in Validating GxP applications
    • Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy
    • Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents.
    • Perform all aspects of QMS (Quality Management System) processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems.
    • Ensure appropriate regulatory requirements are addressed in the validation protocols.
    • Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification
    • Author Reports and Trace Matrices for the computer/computerized systems.
    • Perform gap assessments on vendor executed protocols, ensuring compliance is met and maintained.
    • Support risk assessments and impact assessments following applicable SOPs.
    • Provide guidance/support during specification (URS, FS, DDS or CS) document generation and review..
    Professional Skills -
    • Excellent written and oral communication to include accurate and legible documentation skills.
    • Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic.
    • Microsoft Office and database management skills.
    Experience
    • At least 8+ years of relevant computer systems validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments in a Pharmaceutical or CDMO industry.
    • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus.
    EDUCATION
    • Bachelor's degree in Engineering/Pharma/Lifescience, Computer Science in related discipline or equivalent.
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