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Senior scientific expert, qa support functions

Bern
SThree Germany
Inserat online seit: 26 November
Beschreibung

Senior Scientific Expert, QA Support Functions (m/f/d) Location: Bern, Switzerland Duration: Temporary position, 12 months starting from 24 November 2025 Responsibilities: * Ensure compliance with GMP requirements across Quality Control, Ongoing Stability Studies, Maintenance & Utilities (including requalification and revalidation), Warehousing, and Internal Transport. * Manage and approve deviations, lead initial risk assessments, support root cause investigations, define corrective actions, assess product and process risks, and finalise investigation reports (in German or English). * Oversee change control processes as Quality Delegate, including classification, approval, assessment oversight, and implementation status activation; participate in global change control panels. * Provide on-site quality decisions ("Quality on the Floor") and conduct periodic walkthroughs with operational teams (e.g. in warehousing). * Participate in regular meetings with operational departments to ensure timely closure of deviations, corrective actions, and GMP-relevant changes. * Support the team during regulatory inspections. * Conduct technical review and approval of GMP documents from relevant departments. * Contribute to projects and support system and process optimisation initiatives. Requirements: * Master's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or Law. * Native German speaker with advanced English skills (C1), both written and spoken, along with strong communication and presentation abilities. * Minimum 3 years of experience in deviation and CAPA management within a GMP regulated environment, including regulatory communication. * Proficient in IT applications. * Technical knowledge in Maintenance & Utilities, analytical methods, stability studies, or logistics processes is advantageous. * Strong analytical thinking and ability to present complex topics in a clear, structured manner. * High level of independence, initiative, and responsibility. G* Enjoys collaborative teamwork across departments. In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder. SThree_Germany is acting as an Employment Business in relation to this vacancy.

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