Quality Expert for AVI Requalification & Error Analysis

With over 30 years of experience, he has managed the complete procurement, specification and integration of laser-based production systems including AVI systems and serialization solutions

As a technical project manager, he independently managed CAPEX projects with budgets up to €30 million, overseeing timelines, resources, FAT/SAT and supplier coordination

Proven expertise in the validation and commissioning of laser systems within GMP environments, ensuring compliance and operational efficiency

Deep experience in stakeholder management, reporting to steering committees and proactive risk management in highly automated lines

Leading the upgrade of two existing filling lines to the latest technical standards, including laser systems for visual inspection and serialization

Tendering, selection, and procurement of laser inspection systems for automatic visual inspection (AVI) of parenteral products

Responsible for the entire FAT and SAT execution in close coordination with suppliers, including test protocols, acceptance criteria and error logs

Method validation with HGA using laser absorption spectroscopy for leak detection in sterile containers

Project management according to GMP & ISO 13485, resource planning, reporting to technical management & QA

Troubleshooting at line level, technical management in improvements & qualification tasks (IQ/OQ)

Modernization of vial labelers to comply with global Track & Trace requirements, including integration of laser marking system

Solving complex laser printing issues, such as multiple printing on pre-printed labels

Leading FAT/SAT processes for new visual inspection systems in collaboration with suppliers

Validation of AVI systems for parenteral products using HGA and KNEAT

Validation of new PAT technologies with Raman spectroscopy for real-time monitoring of critical parameters in the scale-up process

Managing technical project teams, milestone planning, change management, CAPA

Technical responsibility for the procurement and automation of lines for tableting, capsule filling and visual inspection

Introduction of Rockwell FTPS & WMS with connection to ERP and SCADA systems

Leading FAT/SAT processes with suppliers, checking applications on-site, and planning acceptance

Ensuring CSV compliance and validation coordination (URS, FMEA, Trace Matrix)

Supervising commissioning processes and training production managers

Quality support until GMP-compliant handover

Overall responsibility for the modernization of a packaging line, including integration of new automation technologies, HMI software, sensors and actuators

Serialization project with integration of laser printing systems for product labeling and global Track & Trace according to EU/FDA guidelines

Error analysis & resolution of a complex problem with laser printing (multiple printing on pre-printed labels) in collaboration with the supplier

Creation and review of CSV documentation (URS, FDS, IQ/OQ) for the new line

Close collaboration with engineering, quality, and global IT (SAP ATLAS, ATTP)

Accompanying FAT/SAT processes at the supplier for laser and labeling components

Support for the validation of software interfaces (MES/SCADA)

Project management including resource planning, status tracking, risk management

Overall responsibility for the requalification and validation of automated visual inspection systems (AVI)

Leading root cause analyses for deviations in the visual inspection process, handling international complaints, and CAPA management with interface function to QA, production and technology

Conducting Annex-1 gap analyses and risk assessments for existing inspection processes

Revalidation of laboratory and production systems including documentation (URS, IQ, OQ, PQ)

Technical support for process deviations, e.g., glass breakage and material issues

Coordination with contract manufacturers and external partners in a regulated GMP environment

Overall responsibility for the planning & implementation of Werum PAS-X at four pilot sites worldwide

Involvement in the procurement of automated lines, including tableting, visual inspection and packaging

Conducting and technical leadership of FAT & SAT for software applications, MES integrations and interfaces to SCADA

Creation of DQ/IQ/OQ documentation

Support for IT/Automation concepts

Technical stakeholder management with regular reporting to global project boards