Quality Expert Junior

vor 4 Wochen

Neuenburg, Schweiz CK Group Vollzeit

CK QLS is seeking a Quality Expert Junior to support quality System documentation and continuous improvement efforts in compliance with relevant standards. The person will join a Global Pharmaceutical company based in Neuchatel. Duration : Until the end of the year The primary responsibility of this role within the Quality organization is to perform activities related to the documentation process and system, including archiving activities, provide user support for documentation-related tasks, contribute to continuous improvement efforts and site initiatives, and ensure adherence to internal procedures and regulatory requirements. System Ownership and user support Act as System / Process Owner or Administrator for the assigned process(es) / system(s). Maintain the Documentation Quality System, including proper archiving activities. Assist end users with processes or systems in area of responsibility and with resolution of issues. Train users and manage associated training toolkits. Process users accounts requests for the system(s) in area of responsibility. Create, update, approve and archive documents in area of responsibility. Continuous improvement and site initiatives Acts as Quality Representative in both routine and Company facility projects to support the quality system deployment and application to meet the current Regulatory Requirements. Compliance Support for regulatory agency inspection and internal audits, closure of observations / audit items and regulatory submissions. Support the preparation of the local, Biologics Operating Unit and Global Quality Councils, if applicable. Support Gembas in GxP and non GxP areas Critical / Key skills Degree in pharmaceutical sciences, life sciences, or a related scientific discipline. Minimum 2 years of experience in the (bio)pharmaceutical industry, ideally in a multinational company. Knowledge with GMP and regulatory guidelines (e.g., US-FDA, EMA, ICH). Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles. Knowledge of document version control, document workflows, and archiving. Awareness of audit and inspection readiness requirements. Proficiency in using electronic document management systems (Veeva Vault). Proficiency in French and English (minimum B2 level or equivalent). Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint. Ability to drive change and continuous improvement mindset. Ability to train end-users on systems and processes. Capability to troubleshoot quality-related issues and propose effective solutions. If you are interested, please send an updated CV by email at #J-18808-Ljbffr

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