You assist in the GDP administrative batch control procedure. You identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives. You keep up to date with new and developing regulations related to GDPs and GMPs. You act as data administrator in coordinating complaints (quality defects, adverse events) You support QA in data and document collection for regulatory purposes. You support QA in ensuring ongoing inspection readiness in your areas of responsibility.
You hold a Master degree in pharmaceutical sciences/engineering/(bio)chemistry or are equivalent through experience. You have at least 5 years of relevant experience in QA in the pharmaceutical industry. Being approved as a Qualified Person is an asset (EU release of medicines) You have good knowledge of the relevant European regulations for pharmaceutical products. Knowledge of FDA regulations for pharmaceutical products is a plus. You are a self-starter, capable of working autonomously at corporate level. You are also a clear communicator, practical and solution oriented. You have a 'getting things done' mindset. You have strong project management skills as well as perseverance in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills. Being a team player who can adapt to a multicultural environment is key. You are willing to travel regularly (1-2 x/month). You speak and write English fluently. Other European languages are an asset.
Our offer :
A key QA position in a growing organization. An appealing international career opportunity in a dynamic, strong growing multinational company environment. Apart from a competitive remuneration pack (including pension plan, hospitalisation insurance,…), we offer you excellent personal development and growth opportunities
Key words - QA , quality assurance , GDP , GMP , Belgium , GDP , GMP , QA