Validation expert (lab/pharma)

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 55,000 staff across a network of more than 1000 independent companies in over 50 countries and operating more than 900 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins Professional Scientific Services® (PSS) is a global, award-winning insourcing solution. Eurofins PSS employs and manages full-time analysts, technicians, scientists and technical support personnel directly at the client facility to provide long term staffing needs while maintaining the same services, expertise and cGMP compliance available at the Eurofins facility. Eurofins PSS offers excellent career opportunities for people who have a proven track recording in combining excellent technical ability with first class interpersonal and communication skills.

Job Description

Part of our Method validation, stability and trending team you will provide CPV/trending reports.

Utilize data trending and statistical analysis to:

• understand process and deepen knowledge.
• Detect issues in process capability, such as systematic quality defects.
• CPV trending (Issue data trending report).
• Ensure data and trending is visible and communicated to different stakeholders

Support or manage following activities

• issues/risks detected through CPV, AQR/PQR,
• investigations,
• improvement projects,
• product or process change controls

Liaise with multidisciplinary functions (Quality Assurance, Quality Control, Engineering, Regulatory) with focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product/process in constant state of validation

Qualifications

• Experience with Minitab or other statistical software. You must have a basic knowledge of statistics.
• You must be capable of updating documents/SOP’s based on information supplied and gathered.
• Must be able to propose decisions based on data analysed. You must be capable of interpreting process data.
• Good Experience and understanding of GMP
• You must be capable of respecting timelines and meticulous.
• You must be capable of communicate with different departments and different hierarchical levels.
• Fluent in English and ideally French or Dutch.

Additional Information

• 6 months contract, full-time
• 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.