QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er in Toxicology.What do we expect from you as anExtractables and Leachables Specialist?We are seeking a specialist with advanced knowledge in the identification and analysis of extractables and leachables, capable of contributing both to laboratory studies and the preparation of detailed risk assessment reports. The ideal candidate will have experience in advanced analytical techniques, including mass spectrometry, and a deep understanding of toxicological risk assessment related to these types of impurities.Technical Knowledge and Skills: Advanced knowledge of analytical techniques: GC-MS, LC-MS, HPLC, ICP-MS, and other relevant methods. Ability to perform and document toxicological and risk analyses according to industry standards. Strong understanding of international regulations and Good Manufacturing Practices (GMP). Skills in technical report writing and regulatory documentation generation. Knowledge of toxicology evaluation and materials science applied to product safety. Personal Competencies: Strong analytical thinking and attention to detail. Ability to work effectively in a team and communicate with other departments. Proactivity and the ability to solve problems independently. Adaptability and a commitment to staying current in technical and regulatory knowledge. Who are we looking for? Bachelor's degree in Analytical Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related fields. Postgraduate studies in Toxicology or Pharmaceutical Sciences are preferred. Minimum 3-5 years of experience in the pharmaceutical or related industries, with roles focused on the analysis of extractables and leachables. Hands-on experience in mass spectrometry and other advanced analytical techniques applied to extractables and leachables studies. Experience in toxicological evaluation and risk analysis of impurities in pharmaceutical products is desirable. A true QbD'er can be recognized by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challenge Hungry for knowledge: You are always open to learning No non-sense mentality: you can be straightforward in a respectful way Innovative: You are constantly looking for new and better solutions (Not too) serious: your job is serious, but you don't take yourself too serious. What's in it for you? QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. As we're a knowledge-based company, you're guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an award-winning company we value everyone's contribution and celebrate achievements together Our promise to you: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done! Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
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