Covance

  • Research Assoc II Biotech

    Job Location(s) UK-Harrogate
    Job Number
    2018-18433
    Job Category
    Scientific Bachelor's Degree
    Position Type
    Full-Time
  • Job Overview

    The individual has a responsibility to work with BioPharmCMC Operations and BioPharmCMC Management where appropriate to conduct all work to cGMP as specified in the quality and equipment management documentation or work governing the work in which they are involved.

    These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

                                                                    

    • Adhere to and/or complete all equipment documentation. This includes, but is not limited to:
      • Standard Operating Procedures (SOP)
      • Equipment Training Documentation
      • Metrology Specification Requests (MSR)
      • Equipment Qualification Documents (e.g., IQ/OQ/PQs, job tasks)
      • Other equipment validation documents (e.g., risk assessments, URS, etc.)
      • Supplier Approval Request Forms (SARF)
      • Asset Management System (TMS) Forms
      • Work Orders
    • Coordinate with in house or vendor maintenance and qualification activities:
      • Work with Operations to determine appropriate timeframe for maintenance
      • Schedule maintenance with Facilities Management (FM)
      • Escort vendors during maintenance and qualification activities
      • Ensure vendors meet GMP compliance requirements (i.e., approved supplier, training documents obtained, etc.)
      • Manage “Do Not Use” tags to ensure instrumentation downtime is minimized
    • Where required arrange for the installation and set-up of new equipment.
    • Complete GMP quality records to an appropriate standard related to equipment failures and changes:
      • Deviations
      • Change Controls
      • CAPAs
      • Audit Comments
      • Compose documents from concept
        • Write IQ/OQ/PQ documents for internal execution
        • Compose SOPs and Policies as QDMS author
    • Serve as the subject matter expert (SME) and main point of contact for equipment validation and processes. 
    • Arrange purchases for EM Team or Operations
      • Gather quotes / contracts from appropriate service providers
      • Execute PO Requisitions / ePro submissions
    • Approve documentation completed by other associates with instrument knowledge confidence
    • Engage in improvement initiatives towards a singular process for all EM processes and documents.
    • Work on process harmonization across GMP sites (SOPs / IQOQPQ documents)
    • Coordinate / collaborate on continuous process improvements across GMP sites
    • Assist Global Business Technologies (GBT) and other areas of Global Laboratory Systems to assist in computer system validation (CSV) activities:
      • Determining the scope of the validation testing
      • Test script execution
    • Serve as SME for complex analytical instrumentation (e.g. HPLC, UPLC, Mass Spec)
    • Coordinate large project scopes to ensure proper execution and timely completion
    • Prioritize GMP EM Team function
      • Prioritize daily responsibilities of associates according to business needs
      • Determine associates area of GMP EM responsibility and determine cross training opportunities
    • Act as the lead individual in client and regulatory facing audits and visits.

    Education / Qualifications

    The post holder should a have a techincal or scientific qualification (degree / HND / HNC and / or a commensurate level of industry experience.

    Experience

    • 5+ years proven experience within an equipment validation role.
    • Demonstrable knowledge of system validation procedures and expectations.
    • An in depth knowledge of industry standards relating to equipment validation.
    • Poven knowledge of GMP quality systems.
    • Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
    • The ability to communicate effectively at all levels, with other employees, as well as external clients, engineers, suppliers, etc.

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