PpFor our site in Visp we are looking for a dedicated Batch Record Reviewer 80 - 100% (f/m/d) to extend our team. If you are passionate about applying your expertise to optimize drug product manufacturing and truly make a difference, we encourage you to explore this opportunity. /p bKey responsibilities: /b ul liResponsible for the planning, the execution and documentation of manufacturing campaigns for Drug Product in compliance to cGMPs, SOPs and applicable guidelines. Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements. /li liProvides front line technical and procedural support, working with the manufacturing teams (operators), plant engineers and QA operations. /li liResponsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area. /li liLead process related investigations and critical deviations and assists in decision making on production issues. /li liLead process changes, CAPAs, and CAPA effectiveness checks related to process within required timelines and through GMP systems (e.g. Trackwise, MES, training, etc.). /li liSupports the execution of process validations, including planning and preparation of the required validation plans and reports, liaising with all the relevant parties at shopfloor to ensure accurate execution. /li liUse scientific, process and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures. /li liBe highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis. /li liBe a resource to other departments as Subject Matter Expert for the product and process knowledge. /li liProvide training for assigned new processes and products. /li liActs as Subject Matter Expert during customer audits and visits, maintain their processes at inspection readiness level and to provide the necessary support. /li liResponsible to prepare and execute SHE, EM and operation risk analysis for the assigned products and the implementation and control of defined measures. /li liExecutes innovation and improvement projects comprising general manufacturing aspects for the production plant. /li /ul h3Key requirements: /h3 ul liPreferred area of study: Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. /li liExperience in Sterile Manufacturing on the shopfloor and/or QC/QA in an asset. /li liFluent in both German and English. /li liFamiliarity with GMP requirements, quality procedures and SOP execution. /li liStrong leadership skills and team orientation. /li liGood communication skills and interaction with a variety of interfaces within the organization and on the shopfloor. /li liStructured, focused and well-organized working attitude; open-minded for new ideas and suggestions. /li liHigh motivation and dynamic drive; solution-oriented. /li liProven IT knowledge, knowledge in ERFP (SAP) or MES (Syncade) is an asset. /li /ul pbPrepared to work flexible working hours. /b /p /p #J-18808-Ljbffr