Quality Expert

More than 30 years’ experience of quality management in the pharmaceutical industry

He has worked for CMOs as well as with CMOs and therefore has a lot of expertise in CMO-Management and transfer projects

Familiar with all dosage forms (liquids, solids, semi-solids and sterile produced), also as head of production

Certified GMP Auditor

Leading of more than 100 people

Production planning with SCM

CAPAs, Deviations, Changes, Complaints

Review and Release of MBRs and EBRs

Part of SLT and Steering Committee

Solida, Liquida and sterile production

Develop and implement new validation and CPV approach

Preparation SOPs regarding the new approach

Training of internal employees

Participate at customer and authority audits as SME

Execute multiple validation projects with customers

Develop of a cost calculation tool for process validation and additional services

Organization and leading of audits at API-Supplier and CMOs

Develop and implement a qualification process for NEMs

Implement a single point of contact concept for external cooperations partner (supplier and customer)

Execute the position of single point of contact

Organization of change control, deviation, complaints, and common questions with external partners

Negotiation and preparation von quality-agreements with supplier and customer from draft until signature

Deviation management, change control and complaint management including RCA and corresponding CAPAs

Review of master batch records and batch records

Process validation including preparation and review of RAs, protocols and reports

Preparation and execution of equipment qualifications

Preparation and execution of audits (Drug substance and Drug product)

Preparation and review of PQRs, CPV-Activities, creation of stability studies incl. protocol, ongoing-report, evaluation, and final report

Supplier qualification including quality agreements for drug substances and drug products

Project management for reformulation and validation projects

Review of dossier documents

Preparation and review of SOPs

Preparation, execution of multiple self-inspection and audits

Implementation of a GMP-Training software including CSV

Lead of Project “New Labeling Concept” with regard to the implementation of SAP including qualification and validation

Support CSV team in validation of multiple transaction in SAP

Qualification the corresponding equipment

Reorganization of quality department (QA/QC) with cost reduction of 4 million €

Re-evaluation of timely effort for QC activities including pareto analyses and corresponding improvement opportunities

Redesign of QC-Layout

Support QA-team by redesign of complaint- and deviation management (CAPA) and change control procedure

Development of the company and integration with another company

Responsibility for all activities and budgets including the cost centers production, maintenance/engineering, SCM, QC/QA, EHS and R&D

Determination of variances, KPIs monthly in cooperation with controlling and reporting of these data to corporate

Approval and management of all Company Wide Investments (e.g. equipment, infrastructure, validation, registration)

Implementation of an effective project management in consideration of a Lean Six Sigma program including a integrated production system

Cooperation with national and international partners and authorities to achieve short term and long-term goals

Formation of new strategies in cooperation with Marketing and Sales regarding product portfolio and market development

Responsibility for the site: sales, capital investment activities and quality systems

Progression of site and corporate-wide production systems

Implementation of corresponding KPI based on strategic and operational goals

Secure sales targets with regard to validation projects, reformulation projects and pharmaceutical studies including additional sales by analytics and analytical method development

Implementation of the new validation concepts CPV with key customers

Participation on customer and supplier audits as well as on authority inspections (e.g. German, FDA, CFDA, ANVISA, Turkey, Kenia)

Responsibility for all engineering activities on site starting with investment application until the transfer to production

Implementation of an energy management system ISO 50.000 including internal and external audits

Reprocessing of the quality systems: Deviation Management, Complaint Management, Change Control, Risk Assessment to align the processes

Direct disciplinary lead of 18 people from different sciences (e.g. Pharmacists, Chemists, Engineers) and subject specific