Approximately 25% products are manufactured internally (8 plants spread over Europe) while the remainder is outsourced to specialized third-party contract manufacturers, mainly based in Europe.
We are looking for a hands-on Quality Assurance Manager who can lead the Global Quality Assurance Food department in integrating and maintaining the Local and Global Quality Management System.
You will act according to the Global Quality Assurance (QA) vision, strategy and procedures for the integrated Corporate & Country QA group. You will lead the team in as well as execute the following activities: You will agree Quality Agreements and Technical Quality files with third parties (mainly contract manufacturers You will help with due diligence and integration of new product developments / new product introductions. You will support technical transfers, qualification and validation work. You will investigate quality incidents, deviations and complaints, identify and follow-up CAPA's and improvement plans together with third-parties (contract manufacturers). You will evaluate and follow-up Change Controls together with the Regulatory Affairs team. You will agree stability programs. You will be part of third-party qualification and regular third-party auditing. You will maintain databases and documents according to good documentation practices and record retention procedure. You are responsible for updating and executing the annual sampling plan. You are responsible for updating raw material archive. You will be responsible for executing product risk analysis. You will maintain licences for organic products (food & cosmetics). You are responsible for the set-up of a batch control procedure. You will assist in the GDP administrative batch control procedure. You will act as data administrator in coordinating the complaints (quality defects, adverse events) across the full Pharma business.
You will directly report to the Head of Global QA Medicines / Food
Master degree in (pharmaceutical/biomedical) sciences, engineering, (bio)chemistry,… or equivalent through experience. You preferably have 8 years of relevant experience in quality assurance.
Good knowledge of the relevant European and Belgian food regulations and (ISO) standards. You preferably have experience in botanical extracts and food microbiology. You possess general knowledge of Belgian and European medicinal regulations. Good people management skills Self-starter, capable of working autonomously. Clear communicator, practical and solution orientated. Enthusiastic and hands-on. Strong project management skills & team worker. Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills. International travelling (1 x months) is inherent in this role. You speak and write fluently English. Other languages are an asset.
Our offer :
? A key QA position in a growing organization.
? An appealing 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, depending on your level of education, expertise, skills and experience.
Key words /key word:QA , Quality Assurance Manager , CAPA , team leader , EU role , Europe, GDP, QA Manager,Belgium