Computer System Validation consultant - Seattle - Futran Tech Solutions Pvt. Ltd.

    Futran Tech Solutions Pvt. Ltd.
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    Description

    Validation Specialist with LIMS

    This role involves overseeing the validation of computer and IT systems, including those used in manufacturing processes.

    Key Responsibilities:

    • Author, execute, and review validation documents such as project plans, protocols, reports, risk management tools, gap analysis, CAPA, and exceptions/deviations.
    • Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems.
    • Schedule and execute validations according to ASTM, GAMP V, standard operating procedures, and regulatory guidelines.
    • Lead validation-related investigations and conduct data integrity assessments with remediation planning.
    • Drive continuous improvement efforts on all aspects of validation.
    • Assist in resolving issues arising from internal quality assessments/audits, regulatory inspections, and notified body interactions.
    • Foster cross-departmental relationships by representing Validation at team meetings.
    • Employ good document practices when recording data, maintaining archives, and drafting/reviewing documents.
    • Demonstrate technical expertise to define approaches and execute system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9, and applicable regulations and industry standard procedures.


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