Alireza Zarei

• Global Team Member for Digital Solutions • Analyzing business impacts and evaluation of corresponding measures • Setting up a global Business Support for GxP applications • Establishing global Demand Management and Employee Qualification Concept • Providing CSV support for a global LIMS implementation • Single Point of Contact for organizational matters related to digital solutions • Project Management and harmonization activities between sites • Ensuring compliance in global procedures

• Expert for digitialization in the life science industry • Creation and management of a highly specialized life science quality team • Creation and management of an internal quality management system based on GxP requriements • Creation of an IT team for life acience software development • Contracting, accounting, business development, reporting, corporate strategy development • Learning solution development, prototyping, software concept creation, personal management

- Biotest Next Level Production Unit Coordinator - Coordination of sampling management, laboratories, compliance activities and ressource planning - Commissioning of new production building and mangement of engineering runs, transfer runs and related activites - Check and adaptation of corresponding SOPs - Ensuring compliance through all processes - Preparing simulation scenrarios for the pre-production runs

-Mitarbeit bei der Implementierung eines globalen Environmental Monitoring Systems (Novatek) -Harmonisierung von globalen Prozessen in Zusammenarbeit mit MSOs -Erstellung und Implementierung lokaler und globaler Schulungskonzepte -Unterstützung bei CSV Dokumentation und Maßnahmen -GAP Analysen und Evaluierung der RA sowie Abdeckung entsprechender Maßnahmen -Organisation und Leitung von Team und Mgmt Meetings -Bewertung der Softwaresegmente gemäß Data Integrity und CFR 21 part 11

Computer System Validation of a LIMS (Labware) System / Project Member for the validation of a GAMP5 software / Creation of Data Integrity realted GAP Assessments / Creation of customized Test Plans / Crystal Report and SAP Interface validation / Allignments with Global Quality, local CSV and IT groups / General validation and audit support

Lead of Computer System Validation for the implementation of a Global Environmental Monitoring (EM) System/ CSV Compliance, Change Control, Risk Assessment, CSV documentation etc./ GAP-, Process Analysis, development of a global roll out concept/ Creation of training documents, translations, Establishment of a global Key-User Community, 2. Level Business Support/ Demands, Alignment with Vendor and IT/ Analysis of processes in C/D Area, aseptic production and laboratories for EM activities/

- Stabilität Überwachung pharmazeutischer Erzeugnisse, Stabilitäts Planung - Behörden Vorgaben, Dokumentation, Produkt Lizenzen / Spezifikationen - OOS, OOT, Deviation, Complaint, CAPA, Investigation, Root Cause Finding - Methoden Transfer, Methoden Validierung, Methoden Optimierung - Global Project Management - Trackwise, SAP BW

Project Manager in a global project team Implementation of a global Trackwise application (Complaints, CAPA, Deviations etc.) Project Manager for the implementation of a global reporting platform (Tableau) Project Manager for the development and implementation of new interfaces between databases, reporting systems and EQMS Validation of databases, processes, ERP systems (SAP) and EQMS

Participation in the development of a global Trackwise system (Complaint, CAPA, Deviation etc.) Team member in various global deployment – und rollout projects Global Trackwise Subject Matter Expert (SME) Lead of the Trackwise Run organisation Key User Community Manager Release Manager Demand Manager Change-Management Onboarding of new employees Validation of processes and Trackwise system Project management, document management and creation of training materials (SAP BW, SAP QM etc.)

Projektmanagement im Bereich der pharmazeutischen Produktion.

Method Development and Validation of new analysis methods regarding particles in the pharmaceutical production.

Responsible for Release Analytics and Complaints.