Responsible for ensuring that internal and external audits are conducted following international regulations and standards requirements.This person adds value to the organization on the grounds it is also in charge of documental and change order module system improvements, so as they both meets their related standards. The overall role demands this partner to add value on the Quality System Management compliance.Key AccountabilitiesConduct internal audits and participate in external onesContinuous improvement for the Quality System ManagementPlan, design and manage electronic document and record management system (EDRMS) ensuring GMP and specific ISO regulations compliance for electronic document and record management control systemOptimize Change management system throughout the SAP change order moduleEnsure that all activities are performed accordingly to the Quality Management SystemReport metrics of the departmentProvide guidance and monitoring to all direct reportsBe capable of decide the priorities of the departmentLead internal follow up meetings of the departmentTrain the staff in the new processes or improvements related to Audits, EDRMS or Change Order module capabilities.Networking/Key relationshipsTo be determined based on department needs, to include interactions such as:All departments of the companyNotified Bodies and Competent Authorities representativesQuality Systems and Compliance Werfen counterpartsMinimum Knowledge & Experience required for the position:EducationRequired: Bachelor's degree in any related area with the business.Valuable: Any additional degree higher than the required previously.ExperienceProfessional experience is required, minimum of 5 years in a similar position.Additional Skills/KnowledgeInternal/External Audit expertiseSoftware: deep expertise in Office Tools (mMcrosoft), required knowledge in SAP and EDRMS.Language: Fluency in Spanish or Catalan. Advanced knowledge of English (readingand speaking).Standards: knowledge of Quality Regulations applicable to the company.Skills & Capabilities:Methodical and well-organized personTeamworkAbility to express information clearly and concisely to the staff, ensuring comprehensionAbility to apply a systematic approach and constant control, follow-up and verification of the resultsAbility to collaborate, participate and coordinate actively with working groupsReflects values of Werfen in the quality of work and working relationship5-10% of travelling time.Service SpecialistThe Service Specialist will take care to ensuring quality and efficiency of the service offered to support the business...Job Summary Responsible for ensuring that internal and external audits are conducted following international regulations...Job Summary The mission of this position is to guarantee that the Standards under which the Quality System is based are...#J-18808-Ljbffr
