Act as a Validation Manager for software related to Production&Manufacturing Execution by:- ensuring that changes are managed according to CSV rules- supporting daily operation of processes and applications-ensuring that processes and systems are always compliant and in a validated state- managing the execution and documentation of testing activities- participating to projects driven with Agile methodology

Managing of Quality Management System compliant with ISO 9001, ISO 22716 and IFS HPC standard by:o leading crossfunctional Quality-related projects (in FlexiProject, Webcon)o validation of Manufacturing Execution System (OPERA MES)o development & validation of documentation management software (DMS)o leading implementation of ISO 14001o Creating and executing Internal Audit Plano Leading and coordinating internal audits, supplier audits (SQA) o Leading root cause analysis (RCA) and CAPA process, 8D, Ishikawa, 5WHY, FTAo Documentation management (SOPs)o Performing Quality Awareness trainings (data integrity, good doc practice, quality tools etc)o Developing KPI for the Departmento Managing Annual Management Review (MR)

o Leading Quality-related projects (Change management; transfers etc)o Create and maintain Quality Systems in compliance with pharmaceutical regulations for the key entitieso Liaise with the local offices, marketing/sales organization, Regional Distribution Center, local distributors, local regulatory teams and Regional transportations, to ensure that the existing and new pharmaceutical quality requirements are known and controlledo Liaise with the global trade team to ensure compliance with the importation processo Provide support by global trade organizations in supporting the preparation of necessary quality documents (Supplier Quality Agreements/Contracts (SQA/SQC))o Monitor product issues in the field and ensure that they are addressed in a timely mannero Ensure that pharmaceutical distributors and key entities with GMP/ GDP activities are regularly auditedo Prepare change controls documentation to ensure quality compliance with regulatory requirements in EMEA Marketso Develop quality improvements

o QMS creation during Green Field stage in compliance with regulations (FDA 21 CFR, ISO 13485:2016)o Developing global and local KPIs for Quality Departmento Finding opportunities for improvements and leading improvements projectso Performing internal medical device Quality Audits as Lead Auditoro Leading Supplier Quality Audits (SQA)o Liaising with local departments to ensure that quality requirements are known and controlledo Building Quality Awareness within organization via trainingso Coordination of nonconformities, Corrective/Preventive Actions (CAPA)o Leading pFMEA / dFMEA analysiso Performing 5 WHY, Ishikawa and 8D reports in order to detect root causes of Quality issues

-QMS Documentation Management (SOPs, Policies)-participating in process validation (Minitab, SPC)-Internal audits managing (ISO13485, ISO9001, GMP)-Coordination of non conformities, corrective/preventive actions (CAPA)-Coordinatiom of customer complaints (8D, PDCA, FTA, 5M, QRQC)-Coordination of change control process-Leading international projects (DMAIC)-Solving quality problems-Performing risk analysis (pFMEA, dFMEA)-Providing support to QP for batch release process-Creation of SMF (Site Master File), Master Batch Record (MBR); PQR (product Quality Review)