Quality Assurance Officer

12 May 2020
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Description

For one of our clients, TRIUM is looking for a Quality Assurance Officer to help proactively manage their quality and compliance of medicinal products.

Function

As a Quality Assurance Officer, you are responsible for the following quality aspects within the business:

  • Help with due diligence and integration during new product developments / new product introductions
  • Agree Quality Agreements with external partners (contract manufacturers, logistic service providers, clients and distributors)
  • Support technical product transfers, qualification and validation work
  • Investigate quality incidents, OOS, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with contract manufacturers.
  • Evaluate and follow-up Change Controls as per company procedure
  • Write Product Quality Reviews
  • Agree annual stability programs and review stability results
  • Be part of Supplier Qualification and Regular Supplier Auditing
  • Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
  • Keep a going awareness of new and developing regulations related to GDPs and GMPs.
  • Support in ensuring ongoing inspection readiness

In addition, the Quality Assurance Officer will act according to the companies’ mission, vision and strategy.

Profile

Your professional profile:

  • You have a master degree in pharmaceutical sciences, industrial pharmacy, engineering, biochemistry, chemistry … or equivalent through experience and have at least 2 years of relevant experience in QA in the pharmaceutical industry
  • Qualified Person certification is an asset
  • You have good knowledge of the relevant European regulations for manufacturing of pharmaceutical products as well as good knowledge of the manufacturing process for injectables and tablets.
  • Knowledge of and experience in FDA regulations is an asset
  • Travel activities is a natural part of the job, so you must be willing to travel in average once a month with an average duration of 2-3 days

Offer

  • You will report directly to the Team Leader QA and will be based in Anderlecht, Belgium or Ireland

Interested in this job?

Send us your CV and motivation to: staffing@triumclinicalconsulting.com