Klaus F.
Freelancer, Consultant & Interim Manager
Experience
Oct 2017 - Present
7 years 11 monthsFreelancer, Consultant & Interim Manager
3P Quality Consulting
- Projects as consultant and interim manager.
- Training Customization
- Data integrity training (basic and advanced training content)
- Root cause analysis and CAPA courses for 40+ employees.
- Risk-Management System Design for Quality Oversight.
- SOP Writing Excellence, incl. use of AI tools (prompting).
- Interim Management (Pharma & Animal Health)
- Implementation of an audit remediation program as person in the plant (PIP).
- Director of a Quality assurance department (6 direct reports), budgeting.
- Operational Excellence & Quality Improvements
- Development of use cases for ChatGPT in GxP context (6 months, part-time)
- Reengineering of processes for a MA holder of generic products, valued operational improvements (Germany, Spain).
- eQMS & document management system - delivery of the business case and investment recommendation.
- Hands-on Support
- Analytical method validation, Process & Computer System Validations, Batch Record Review, PQR-Reviews.
- Articles in International Journals & LinkedIn
- Topics: Modular QMS-Design, Risk-Management in the Supply Chain, Knowledge Management, use of AI for compliance improvements.
Jun 2013 - Sep 2017
4 years 4 monthsAesch, Switzerland
Head Quality System and Strategy
ACINO Pharma AG
- Completed implementation project of the corporate quality management system (ICH Q10), incl. quality manual and 45+ quality directives and their processes.
- Setting-up the regional offices Q-Systems and communication policy with the head-quarter, incl. restart of the GCP QA and pharmacovigilance (PV) systems. Remediation program lead of the PV-QMS system.
- Sound knowledge in CSV methodologies. Workshop led to define business needs for Trackwise redesign. Valued communication with IT-experts to achieve results.
- Corporate Quality Assurance. Reporting line to SVP Quality.
Nov 2010 - May 2013
2 years 7 monthsSaint-Prex, Switzerland
Senior Project Manager Manufacturing Compliance
Ferring International Center S.A.
- Implementation of new FDA validation concept with QbD and product lifecycle background.
- Definition of 50+ QA processes and alignment with stakeholders.
- Redesign of the deviation and CAPA process, IT tools (Trackwise) improvements.
- Set-up of training program to establish “Certified Lead Investigators” – 7 sites worldwide.
- Global Quality Assurance.
May 2010 - Oct 2010
6 monthsBasel, Switzerland
Senior Quality Expert
Novartis Pharma AG (Chemical Operations)
- SAP Data integrity project lead in a line function.
Dec 2007 - Apr 2010
2 years 5 monthsBasel, Switzerland
Project Manager Global Quality Improvement Projects
Novartis Vaccines & Diagnostics AG
- Leading a portfolio of several compliance projects.
- General Improvement Project Manager
- QA Compliance improvement projects in Holly Springs, North Carolina, USA and Ankleshwar, India.
- Certified 6-sigma black-belt
- Right first-time batch records incl. batch record review. Achievement: Substantial compliance and performance improvements. Lead-time - 50%; right first-time rate (60% –> 95%). Black belt certification.
- Throughput-time reduction (median -80%) for complaint handling worldwide.
Aug 2001 - Nov 2007
6 years 4 monthsBasel, Switzerland
Staffposition Head Global Pharma QA
Novartis Pharma AG
- Special projects to gain quality oversight of manufacturing and marketing sites.
- Development of the risk-based quality assurance program for legacy products (Qualimetrics).
- Delegate into the EFPIA working group on ICH Q9 and IPEC Europe.
- Successful project for Head Global Quality Operations; Reorganisation of the stability center Locarno.
- Alliance with country managers. Leading projects to maintain quality oversight, QA compliance, performance and service levels.
- Global responsiblility for quality agreements (100+). Set-up of the centralized system with pharma manufacturing sites and country organisations (CPO). Negotiations with many pharmaceutical companies (CMO).
- System Ownership: Global Complaint Recording System (GCRS). Full lifecycle management. CPO support and training program for 100+ users.
Feb 2000 - Aug 2001
1 year 7 monthsBasel, Switzerland
Global Quality Operations Product Management
Novartis Pharma AG
- Line function, change management API.
Oct 1998 - Feb 2000
1 year 5 monthsBasel, Switzerland
Project Manager Re-engineering Projects
Novartis Pharma AG
- Incl. 4 months stay in stability center Locarno, Switzerland.
Feb 1996 - Sep 1998
2 years 8 monthsBasel, Switzerland
Head of Follow-up Stability Testing (QC/QA)
Novartis Pharma AG
- Responsible for QC/QA stability testing of legacy products.
Feb 1990 - Jan 1996
6 yearsBasel, Switzerland
Head of Analytical Development and Production Control (Quality Assistant)
Ciba-Geigy AG
- Line function to develop analytical methods.
- Provision of HPLC and spectroscopic methods of previously unsolved problems in chemical development: Cyclohexane-hexacarbonic acid, OH-numbers using a new catalyst (internal awards).
- 50+ validated methods for dyestuffs & pigments, modular design of testing instructions.
- Use of multivariate statistics application for UV/vis and NIR spectroscopy.
Jun 1986 - Dec 1989
3 years 7 monthsDüsseldorf, Germany
Head of Laboratory: Analytical Support for Development Projects
Henkel KGaA
- Collaboration with universities (biotechnology, fermenter on-line monitoring, HPLC) & Max-Planck-Institute (GC).
- Provision of HPLC and spectroscopic methods of previously unsolved problems in chemical development: Cyclohexane-hexacarbonic acid, OH-numbers using a new catalyst (internal awards).
- 50+ validated methods for dyestuffs & pigments, modular design of testing instructions.
- Use of multivariate statistics application for UV/vis and NIR spectroscopy.
Summary
Freelance & consulting projects (up to 6 months) - Quality improvements.
Leadership roles in QMS design, quality management & cross-functional collaboration.
Operations and business process re-engineering, GxP enhancement projects, risk management.
Excellent GxP and compliance proficiency (certified GMP auditor), experiences over years in diverse multinational contexts. Proactive leader, passionate and strategic acumen, and strict result orientation - many improvement projects with successful completion.
Good, cross-functional communicator with a holistic mindset.
Calm in dynamic environments, displaying a natural affinity for embracing change, driving improvements, and adeptly navigating through complex challenges.
Languages
German
NativeEnglish
AdvancedFrench
IntermediateItalian
ElementaryEducation
Oct 1977 - Jun 1983
University Siegen
Chemistry · Siegen, Germany
University Hagen
Diploma, focus on organization and planning, Business Informatics · Business Administration, IT · Hagen, Germany
University Siegen
Thesis · 15N-NMR-Spectroscopy · Siegen, Germany
...and 1 more
Certifications & licenses
ASQ Certified CAPA Lead Investigator
Certified 6-Sigma Black-Belt
Certified GMP Auditor
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