Implementation of SAP S/4 Hana and EWM for a renowned gene therapy and biopharmaceutical company in Bavaria

• Worked in a scaled agile framework, being responsible for the collaboration with respective functions from our ART and other affected teams.
• Assess SAP S/4 Hana (MM, EWM) requirements for Gene Therapy Development Center
• Assess business needs and requirements for the interface SAP S/4 Hana (MM, EWM) with partner systems (MES, sLIMS)
• Provide input and collaborate with partners and other Sites about implementing strategies
• Responsible for the User Access, Roles and Training strategy, ensuring all affected stakeholders get the required access at GoLive, ensuring data integrity and compliance.
• Hypercare phase SPOC
• Created the test scripts and overlooked the formal testing activities
• Material Master Data SPOC

• Collaborated with stakeholders to understand business requirements and objectives, ensuring alignment with process improvement initiatives
  • Business Process Mapping
  • Gap Analysis
  • Risk Assessment
• Conducted in-depth process analysis to identify gaps, bottlenecks and areas for improvement, leveraging industry best practices and regulatory compliance
• Leading a cross-functional team (10 pax) to gather user requirements, define project scope, and establish clear objectives for process improvement initiatives
  • Identification and specification of relevant metadata fields and processes (e.g. registration master data, documents types and subtypes, document metadata fields, templates, overlays).
  • Consulting on the definition of data interfacing and workflow logic ensuring compliance with regulatory guidlines
  • Translate business requirements into implementable technical specifications.
• Focused on critical thinking and risk assessment to ensure a lean validation following Computer Software Assurance (CSA) principles.
• Provide input and collaborate with different interdisciplinary teams about the implementing strategies, ensuring timelines and CSV compliance, as well as Data Integrity
• Coordination with SMEs from RA, Quality, IT and integration partners (Veeva, Select docubridge, Trackwise, middleware) to define, translate, and prioritize requirements.
• Worked in an agile framework, being responsible for the creation of user stories, acceptance criteria, process mappings, functional risk assessments, test cases/scripts.
• Overlooked the testing activities and facilitated defect resolution
• Since March 2025 additional role as Training Lead:
  • provide a data governance concept
  • provide a training concept for the various roles and permissions in the system
  • collaborate with internal training admins to create training materials and ensure timely communication to the stakeholders
  • roll-out trainings ensuring compliance with the company?s policy and processes
• Since July 2025 additional role as Hypercare SPOC:
  • Create and/or fulfil ServiceNow requests and incidents
  • Collaborate with stakeholders to gather business enhancement requirements
  • Assess and prioritize new enhancement requirements
  • Work in an agile framework to support the implementation of enhancements
  • Facilitate quick defect resolution and change requests while in a productive GxP system
  • Project handover to internal business teams
  • Provide general support on inquiries from end users regarding the application

Prompt Engineering, retrieval augmented generation, model fine-tuning for a renowned AI Solutions Enterprise

CSV & Compliance Consultant ? generics pharmaceutical company in Bulgaria

• Coached QA Team Leads on general CSV & Data Integrity topics, promoting continuous improvement in the QA and Quality Management Systems
• Supported team with implementation of CSV and Data Integrity strategies to ensure compliance with EU and FDA regulatory guidelines
• Ensure preparedness for future GMP manufacturing

Project Engineer ? Risk Mitigation Project: Commissioning, Qualification and Validation of a newly built production area at a renowned Animal Health company in Austria

• Leading and planning the C&Q and CSV activities (business analysis)
• Development and creation of GMP-compliant qualification/validation concepts
• Creation of deliverables: user requirements specifications, functional specifications, VP, DQ, risk assessments, IQ, OQ, PQ, testing, VR, deviation reports)
• Consulting on CSV & Data Integrity topics
• Support the team in performing SAT activities for various C&Q utilities and systems