QA Officer
il y a 1 semaine
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2021, Eurofins generated total revenues of EUR € 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
**Eurofins CDMO** is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development for chemical/biological entities and drug substance development for biologics. We support small and major biopharmaceutical companies in an innovative way to help them achieving their (pre)clinical milestones timely. Our solid track record in developing and manufacturing New Biological Entities (NBE)/New Chemical Entities (NCE) is one of our strongest asset. Our facilities are perfectly designed for small clinical and/or commercial batches either for sterile or non-sterile dosage forms. With approximatively 400 staff, we operate out of 10 sites either in France or Belgium.
**Job Description**:
- Performing QA related and supportive activities for the GMP compliant production and quality control of Investigational Medicinal Products (IMPs).
- Performing QA document review of the manufactured products and quality supportive activities/services like calibration, monitoring of clean rooms, cleaning of equipment.
- Incoming quality control of raw materials and critical goods.
- Support the qualification of production and test equipment.
- Support the supplier qualification process.
- Support the QA manager/Qualified Person in the maintenance of the Quality Management System and the CAPA system.
- You will report to the QA Manager/Qualified Person.
**Qualifications**:
- A minimum of a Bachelor Degree preferably in life science with two (2) years of experience in a GMP pharmaceutical production environment or equivalent by experience.
- You have basic knowledge of Quality Management in a regulated environment (Eudralex GMP, ICH, FDA).
- You are flexible, quality minded and well-organized.
- You are fluent in English (written and spoken).
Additional Information
- Work in a fast growing organization.
- A position with responsibility within a dynamic company.
- Personal development through learning on the job and additional external trainings.
- A market oriented compensation.
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Administratief bediende
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Zwijnaarde, Belgique Start People Gent (Orban) Temps pleinDescriptionVoor onze klant, een biotech bedrijf in Zwijnaarde, zijn we op zoek naar een sterk administratief profiel die zich kan inzetten als QA Release specialist. Binnen deze functie ben je deel van het quality assurance team. Je bent verantwoordelijk voor:Het beheer van batchgerelateerde documenten (uitgifte, beoordeling, vrijgave en...
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Administratief bediende
il y a 1 semaine
Zwijnaarde, Belgique Start People Gent (Orban) Temps pleinDescriptionFor our client, a biotech company in Zwijnaarde, we are looking for a strong administrative profile to work as a QA Release Specialist. In this role, you will be part of the Quality Assurance team. You will be responsible for:Managing batch-related documents (issuance, review, approval, and alignment).Issuance and periodic review of existing...