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- ...surpass their goals and reach an overall high level of performance (raising the bar) * Protect/breath the team- and company culture (cfr. the way we do things) * Leading by example by closing deals and managing your own sales cycles * Facilitate/support group...
- ...industry and QMS/GxP/ISO frameworks. ~ Extensive knowledge of Quality Management Systems and relevant regulations (GAMP 5, FDA 21 CFR Part 11, EU Annex 11). ~ Experience creating user friendly processes that balance business needs, GxP compliance and IT...
- ...versed in the drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning procedures, and 21 CFR Part 11. Project management capabilities encompass effective group presentation, leadership, verbal and written communication, interpersonal...
- ...continuous improvement initiatives across the production line. Our work is guided by regulatory frameworks such as ISO 13485, FDA QMSR (21 CFR Part 820), and EU MDR, ensuring that each product we deliver is safe, effective, and reliable. Collaboration is central to what we do...
- ...projects, including implementation of AI-related requirements Advise on global medical device regulations including EU MDR, US FDA 21 CFR, and ISO 13485 requirements Ensure compliant technical documentation, labeling, Declaration of Conformity, and product standards...
- ...demands secondary packaging materials (e.g. labels, leaflets, cartons) Familiar with applicable regulations and standards (e.g. 21 CFR 210/211/820/, EMA scientific guidelines on the packaging of medicinal products, ISO 14971) You have excellent English...
- ...Familiarity with ISO 14971 and ISO 13485 Experience with drug–device combination products is a strong plus ~ Experience within FDA 21 CFR 820 and EU MDR is considered a strong plus ~ The ability to work independently, manage multiple priorities, and drive solutions...
- ...minimum of +5 years of experience. Further, it is an advantage if you bring solid knowledge of regulatory standards (e.g. EU GMP, 21 CFR, ICH), and proven experience in inspection readiness, coaching SMEs through audit observations, and the ability to communicate and...
- ...contribute to catalog/metadata. Build security/compliance in: Align with Cybersecurity, data privacy, and where applicable GxP/21 CFR Part 11; execute changes under ITIL/PMO governance. Partner to deliver: Translate business needs into technical designs; balance delivery...
- ...alignment with relevant standards and regulations, including IEC 62366-1, ISO 14971, IEC 62304, IEC 60601-1-6, ISO 13485, EU MDR, and FDA 21 CFR Part 820 Guide R&D teams in applying usability engineering and risk management in development projects Plan, support, and...
- ...Lean leadership and continuous improvement of core processes Direct on current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines. Manage trained employees for our 24/7 on call support People development, high level of employee engagement...
- ...background that allows for understanding of the complexity of manufacturing biologics ~ Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity ~ Knowledge of IT Controls methodologies, including GAMP5 and ITIL. ~ Experience with...
- ...the design of secure automation network topologies. · Strong working knowledge of regulatory frameworks, including GMP, GAMP 5, 21 CFR Part 11, and data-integrity expectations, ensuring automation deliverables meet stringent pharma/biotech compliance requirements....
- ...pharmaceutical, biotechnology, or medical device industry. Knowledge of industry regulations and standards, such as GxP, FDA 21 CFR Part 11, ISO 17025. Experience integrating LIMS systems with other IT systems (ERP, MES, etc.). Competencies and Skills:...