• Senior IT Help Desk- GLP/GMP

    Job Locations US-MA-Bedford
    ID
    2019-1051
    Category
    IT
    Type
    Full Time Salary
  • Overview

    Homology Medicines is searching for a creative, resourceful, and integrative thinker for an important role that is responsible for providing oversight, approval and support of laboratory/manufacturing systems, including: periodic reviews, audits, configuration, testing, and maintenance of a variety of GxP software systems. This role will work with Quality Assurance, Regulatory, Quality Control, Clinical and Manufacturing to enable system validation activities and serve as System Owner. Responsibilities include developing enterprise documentation for IT including GxP processes, IT governance policies and procedures, system administration, system configuration and user account administration. Oversee and manage evaluation, implementation and technical support of software and equipment to insure compliance to GxP standards.

     

    Responsibilities

    • Ability to independently manage small projects, from the initiation phase through to deployment
    • Support users on technical issues related to new and existing systems
    • Extensive knowledge of FDA guidelines and regulations
    • Perform system administration on local and enterprise laboratory/manufacturing systems including: hardware/software setup and configuration, interface to the GMP network, user account setup and group permissions
    • Facilitate documentation to keep laboratory/manufacturing systems in a maintainable and recoverable state
    • Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects
    • Act as business administrator for various applications
    • Perform security audits of IT systems
    • Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, Unit test scripts, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ
    • Develop department SOPs and provide SOP review for new systems
    • May support, coordinate and interface with regulatory agencies as required in support of regulatory agency inspections
    • Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines, such as; qualifying SCADA systems, BAS and BMS system
    • Establishing compliance under US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
    • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
    • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

    Qualifications

    • Bachelor’s degree and a minimum of 7+ years’ experience dealing with GxP computer systems in the pharmaceutical or similar regulated industry
    • A technical background a must
    • Experience supporting/troubleshooting laboratory and manufacturing systems
    • Experience with administration of GxP computerized systems
    • Proficiency in managing Windows and Linux Operating Systems
    • 2+ years’ experience as a team leader of computer system specialist teams
    • Strong understanding of the current pharmaceutical industry and computerized system regulations, including CFR Part11 and GAMP 5
    • Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks
    • Experience in providing oversight in implementing and maintaining GxP computer systems in a validated state

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