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- ...arbetsuppgifter kopplat till renrummen: revalideringar, mikrobiologiska avvikelser, cc-ärenden vid förändringar, produktionsrepresentant vid audit. Övriga arbetsuppgifter som kan förekomma: Fungerar som stöd i reklamationsärenden och driva reklamationsutredningar....
- ...and proven experience working within an international SW organization Minimum 5 years of experience with ISO 9001 compliancy and audits Minimum 5 years hands-on experience with agile SW development, software testing, including familiarity with automated testing...
- ...renrum) • Arbeta med revalideringar, mikrobiologiska avvikelser och CC-ärenden kopplat till renrum • Agera produktionsrepresentant vid audit • Stödja och driva reklamationsutredningar • Delta i förbättringsarbete samt uppdatera produktionsdokumentation • Utföra och...
- ...and internal controls Improve profitability and cost structures across markets and offerings Ensure financial compliance and audit readiness Leadership & collaboration Partner with CEO and executive team on business planning and strategic decisions Lead...
- ...on the Production and Process Change Review Board providing guidance and reviewing proposed changes. Host internal and external audits ensuring readiness and compliance. Provide expert QA guidance and support to other functions. external sources outside of own team...
- ...Core team. Du har även övergripande renrumsansvar för avdelningen (4 renrum), inklusive revalideringar, mikrobiologiska avvikelser och audit-deltagande. Övriga uppgifter inkluderar reklamationsutredningar, förbättringsarbete, uppdatering av produktionsdokument och...
- ...analytical methods, work instructions, and quality systems. * Prepare and present technical documentation, reports, and presentations for audits, inspections, and management reviews. * Promote and contribute to a positive, compliant, and collaborative laboratory culture....
- ...instrument qualifications Present relevant activities during audits Contribute to a positive and collaborative working environment... ...~ Experience preparing QC documentation and supporting audit readiness Skills: Strong understanding of GxP principles...
- ...regulatory standards and internal quality systems. Drive continuous improvement in engineering processes and tools. Support audits and regulatory inspections as a subject matter expert. Represent the System Design section in global engineering forums and initiatives...
- ...investment assessments and business cases Contribute to ERP system and reporting structure development Handle closing processes and audit preparation Collaborate with external accounting partners Who We Are Looking For Requirements: ~4–6 years of experience...
- ...guidelines. Maintain departmental infrastructure including SOPs training materials archives and digital collaboration platforms to ensure audit readiness and operational efficiency. Act as a central liaison between internal stakeholders and external partners ensuring...
- ...simplification of analytical methods work instructions and quality systems. Prepare and present technical documentation and reports for audits inspections and internal/external stakeholders. Contribute to a positive compliant and collaborative laboratory culture....
- ...arbetsuppgifter kopplat till renrummen: revalideringar, mikrobiologiska avvikelser, cc-ärenden vid förändringar, produktionsrepresentant vid audit. Övriga arbetsuppgifter som kan förekomma: Fungerar som stöd i reklamationsärenden och driva reklamationsutredningar....
- ...handling Document Control Risk management Supplier management. Lead the preparation execution and follow-up of internal and external audits including customer audits notified body audits and regulatory inspections if applicable. Collaborate with procurement and supply...
- ...leading lifecycle activities such as upgrades and obsolescence mitigation. Serve as subject matter expert (SME) for automation during audits validations and investigations. Foster a culture of innovation safety and continuous improvement across the manufacturing...