Global consultant for management, quality, operations, supply chain planning of solids and sterile dosage forms or medical devices

Projects and results:

• Optimization of CMO management regarding OTIF, quality KPIs and production readiness
• Implementation of OEE measurement within operations

• Responsible for 4 aseptic filling lines and visual inspection with a team of 150 employees
• Implementation of shop floor management, optimization maintenance strategy and batch record review process

• Head Production according AMWHV for aseptic production
• Strategic CAPEX planning to uplift production capabilities

Leading contract manufacturer in development and manufacture of vaccines and pharmaceuticals. Turnover >250 Mio. €, 1.500 Employees

Responsible:

• Budget up to 25 Mio. € / team of 400 employees
• Responsible for aseptic filling and inspection of pharmaceuticals and vaccines (filling in ampoules, vials and syringes, freeze-drying)
• Continuous improvement of existing production processes
• Manage relationships with health authorities, external customers and vendors

Results:

• Reduction of reject batches by 70% due to process analysis and optimization
• FTE neutral volume increase by 15% due to increased efficiency (introduction visual management, DMAIC for reduction technical stoppages, KATA)
• Technical upgrade to state-of-the-art with CAPEX projects (volume 5 million p.a.) with minimum impact on production output

Global developer and producer of respiratory medicines

Responsible:

• Budget up to 15 Mio. € / team of 130 employees
• Responsible for all manufacturing departments (bulk and packaging) of inhalation products (medical devices)
• Restructuring of the production portfolio with two product launches

Results:

• Successful completion of two FDA pre-approval inspections
• Increased efficiency in production by reducing changeover times (SMED)

Global developer and producer of respiratory medicines

• Process optimization with Six Sigma & Lean Tools
• Coordination and prioritization of improvement projects
• Roll-out and training of Operational Excellence skills at the site

Results:

• Successful Black Belt project, verified savings of 500,000 € p.a.
• Train the Trainer training
• Coaching of 2 Black and 6 Green Belt projects
• Coordination and implementation of improvement projects with verified P&L impact of 1.5m € p.a.

Global developer and producer of respiratory medicines

Responsible:

• Budget up to 3,5 Mio. € / team of 25 employees
• Head of production according AMWHV §12
• Ensuring aseptic GMP production of eye drops
• Production, control and storage of medical products and qualification and process validation according to international law (GMP)

Results:

• Quality improvement due to deep dive root cause investigations (no media fill and clean room monitoring issues)
• OTIF increase from 60 to 95%
• Improvement quality KPIs (on time completion deviation, CAPAs, CC) >90%

Generic pharmaceutical production and logistics of solid dosage forms

• Galenic process development of solid dosage forms
• Continued Process Verification with analysis of critical process parameters (CPP) and quality attributes (CQA)

Results:

• Successful Green Belt project, verified savings of €1,000,000 p.a.
• Reduction of rejected batches rate for two products by 70% through DMAIC projects
• Optimization of project management for process validation (coordination between operations, quality, supply chain) with reduction of lead time by 70%
• Implementation of online PAT (Process Analytical Technology) tool for process monitoring

Global research-based pharmaceutical company

• Assurance of GMP production solid dosage forms, Deviation and CAPA management, preparation and follow up FDA audit

Global developer and producer of respiratory medicines

• Aseptic ophthalmic production
• Head of production according AMWHV §12
• Ensuring qualification and validation status
• Process analysis and optimization

• Process optimization (yield improvement) and technology transfer solids