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USG Professionals

Material Qualification Engineer

Published on Jobat.be 18 days ago

Material Qualification Engineer

Our client is a global biopharmaceutical company focused on human health. Diversity and inclusion is foundational to how they operate and embedded in their Core Values.They achieve the best results by working closely together in an open and approachable atmosphere.

Job description

In this function:

You will be involved in a small team and you will be responsible for carrying out activities that are necessary for the qualification of GMP materials (raw materials, filters, bags, etc.), services and suppliers. You report to the Supply Chain Workstream Lead and work closely with the other BIVV001 Workstreams (Tech Transfer, Manufacturing, Quality, ...) and with Suppliers to collect, evaluate and document information about materials with the aim of qualifying the materials for the intended use. Also writing material spec sheets and Quality Agreements, participating in project deliverables such as Fit/Gap assessments, Onboarding report, KPIs, ... and following up a detailed planning are part of your tasks.

All this must be done according to predefined procedures and cGMP regulations

Main responsibilities:

- Aligning needs with internal users and requesting information from suppliers

  • Determining the qualification approach for new materials, services and suppliers, taking into account compendial and other regulatory requirements
  • Evaluating the qualification results (supplier documentation package, test results, audit reports,....) and writing qualification reports
  • Management of extractable/leachable studies and reports
  • Follow up method validations of Release Tests
  • Follow up Master Data creation (SAP, Lims, ...)
  • Writing Material Spec Sheets
  • Writing Quality Agreements
  • Evaluate and resolve discrepancies and issues during qualification

Profile

Profile:

- Master in a scientific direction, or equivalent through experience

  • Min. 3-5 years relevant experience
  • Knowledge of cGMP in a regulated environment
  • Documentation/administration doesn't scare you
  • Knowledge of compendial requirements is a plus
  • You are a go-getter with strong analytical and problem-solving abilities
  • You take the initiative yourself
  • You are result-oriented, flexible and work independently within the set objectives
  • You have good social and communication skills and you speak and write Dutch and English fluently

Offer

USG Science Professionals links ambitious scientists to exciting projects. Are you itching to put your drive and ambition to work in challenging projects? Then USG Science is right for you because we aim to make maximum use of your knowledge and competences. Your mission: successfully completing diverse assignments thereby boosting our customers' results.
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    10 days left to apply

    Characteristics

    Requirements

    • Bachelor following Bachelor
    • At least 2 years experience
    • Dutch, English

    Offer

    • Permanent
    • Full-time

    Apply before

    • 7 December

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