For one of our clients, TRIUM is looking for a Quality Assurance Officer to help proactively manage their quality and compliance of medicinal products.
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.
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
- 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: firstname.lastname@example.org