The mission of this position is to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where OEM sells the products. Assure that all products manufactured at OEM are designed, manufactured and released according to established procedures. In addition, this role works with specific manufacturing teams to drive continuous improvement of Quality within manufacturing – seeking defect rate reduction, increased manufacturing efficiency, reduced costs, and enhanced customer satisfaction.Key AccountabilitiesReview and approval of manufacturing and general proceduresDevelopment of Quality Improvement plan for manufacturing area of responsibilityMeasurement and reporting of Quality KPIs and metrics for manufacturing area of responsibilityChange Management: evaluate the impact of the proposed changes and management of change controlValidation: Be able to establish a strategy to validate changes. Review and approve validation strategies and the corresponding documentation (protocol and report)Risk Assessment: perform, review and approve the risk assessment performed at OEM to evaluate the impact of changes and non-conformances in the final productParticipate in Internal and External AuditsPerform Quality Training to all personnel at OEMManagement of Non-Conformities and CAPAReview of product Batch Record as neededNetworking/Key RelationshipsThe main interactions are with Operations area and Quality Control.Minimum Knowledge & Experience Required for the PositionEducation/Experience:Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences. Degree may be substituted by relevant skills and work experienceValuable: Any additional degree higher than the requiredRequired Experience: 3 years in a similar positionAdditional Skills/KnowledgeSoftware: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAPLanguage: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)Standards: Knowledge of Quality standardsSkills & CapabilitiesThe ideal candidate for this position will exhibit the following skills and capabilities:Management of decisions under pressureMethodical and well-organized personTeamworkAbility to express information clearly and concisely to the staff, ensuring their understandingAbility 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 relationship
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