Covance

Equipment Management Validation Associate

UK-Harrogate
Job Number
2017-15057
Job Category
Scientific Bachelor's Degree
Position Type
Full-Time

Job Overview

The BioCMC solutions Division in Harrogate is looking for a Equipment Management Associate to join their growing team. 

Responsibilities of the position include but are not limited to:

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., IOPQs, job tasks)
  • Other equipment validation documents (e.g., risk assessments, URS, etc.)
  • Supplier Approval Request Forms (SARF)
  • Total 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 / process
  • Arrange purchases for GMP 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

Education/Qualifications

The post holder should ideally have a relevant scientific degree and/or an appropriate amount of laboratory experience.

 

Experience

The post holder should typically have:

  • Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
  • An understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs.
  • Experience with GCP, GMP, Validation, Audits.
  • The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.

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