WuXi AppTec

  • Systems Validation Specialist

    Job Locations US-NJ-Plainsboro
    Job ID
    2018-3916
  • Overview

    Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small and large molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. Xenobiotic Laboratories is seeking a Computer System Validation Specialist located in Plainsboro, NJ.

    Responsibilities

    Primary Duties and Responsibilities:

    • Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for equipment/systems, laboratory instruments/equipment and systems according to the Good Laboratory Practices (GLPs) and FDA 21 CFR Part 11. Documents includes like System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Business Continuity Plan, Disaster Recovery Plan, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM) and Periodic Review of Computer Systems.
    • Generate a CSV validation plan detailing the scope of work and intent.
    • Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
    • Ensure all work is in line with the site Validation Master Plan, regulations, procedures and practices.
    • Maintain VMP, Vendor questionnaires as applicable
    • Review and execute Computer System Validation protocols to ensure compliance and adherence with applicable guidelines
    • Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
    • Prepare validation summary reports for executed protocols.
    • Liaise with various laboratory function within organization in execution of the Validation program.
    • Communicate Computer System Validation approaches and requirements during planning/audits.
    • Facilitate continuous improvement of WuXi’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi.
    • Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and the WuXi Employee Handbook, and coordinates with IT team activities.
    • Work with equipment/system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures.
    • Track and resolve deviations/exceptions during qualification activities.
    • Prioritize qualification activities in line with the project schedules and timelines.
    • Co-ordinate validation/qualification activities with key stakeholders.
    • Serve as the SME for CSV and maintain knowledge and information in the CSV area of expertise.
    • Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company.
    • Manage Validation contractors to complete on-site validation if required.
    • Other tasks as assigned.

    Qualifications

    Qualifications:

    • Degree (Bachelors or Masters) in Computer/Electrical Engineering or other relevant Science Field.
    • Prefer at least three (3) to four (4) years of Computer System Validation experience working in a regulated, GxP environment.
    • Extensive, in-depth knowledge and understanding of Good Laboratory Practices (GLP) and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11.
    • Experience with the following applications/systems is preferred: Analyst, Debra, Laura, Watson LIMS, AIDA and other typical regulated lab systems.
    • Experience with Electronic Data Management Systems.
    • Ability to work effectively under pressure, handle multiple projects and meet deadlines
    • Strong verbal and written communication skills, good decision making skills and time management skills is a must; ability to interface with all levels of the organization
    • Ability to lead Computer System Validation projects for the site
    • Ability to write technical documents (like Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)

    We are an Equal Opportunity Employer.  Minorities/Women/Veterans/Disabled.

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