GMP experience is an absolute must.
* Be responsible for the incoming data from external partners
* Reports/data need to be verified for accuracy and compliance and processed internally onto the company data system.
* Open effective networks of communication with external partners for additional clarification and data integrity.
* Generate scientific documents to hand over to internal and/or external partners (e.g., TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
* This role is complex as you will be interacting with a huge and varied amount of testing sites and therefore need to be flexible, approachable and well-organised.
* Due to strict deadlines, the ideal candidate will be very well organised with time keeping and will be able to work under pressure well.
* Provide scientific and technical guidance. Coach team members as needed.
* Contributes to the setup and optimization of infrastructure or specialized facilities e.g. cell culture or biosafety labs as an expert.
* Contribute to risk analyses and/or peer review and project challenge meetings.
* Interact/collaborate with other groups/functions to facilitate validations, transfer of knowledge/analytical procedures and deliveries of DS and/or DP.
* Give guidance to team members and work according to appropriate SOP's, GMP, OQM, HSE, ISEC and Novartis guidelines.
* Work according to appropriate SOPs, GMP, QM, HSE, ISEC & Novartis Guidelines.
* Successfully demonstrated several years (minimum of 3 years) of directly related experience as scientist or Ph.D. (0 years' experience) or equivalent.
* Solid knowledge of cGMP
* Broad scientific or technical knowledge in a specific area.
* Adequate understanding of development/QC processes in own function.
* German and English (oral and written)
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