Lothar Kaske
External Consultant in the QA Qualification & Validation Department
Experience
Jan 2025 - Present
7 monthsTraining doumentation of pharmaceutical maschines
- Creation of a new structure and pilot creation of training documents for various machines for the pharmaceutical industry with learning objectives, learning content and learning success monitoring
Mar 2024 - Dec 2025
10 monthsQA Manager Qualification/validation
Biopharmaceutical Company
- Review and correction of GMP documents such cuments DQ, IQ, OQ and PQ, as qualification do technical documentation, CAPA ́s, deviations and risk analyses for various pharmaceutical plants in English. (See also Curevac assessment).
Oct 2023 - Feb 2024
5 monthsLOTO / KSE documentation
pharmaceutical company
- Creation of KSE and LOTO-SOP's for systems in the areas of liquid and solids production, liquid and solids packaging, infrastructure (HVAC, CIP/SIP, media), laboratory and warehouse in a pharmaceutical company.
Apr 2022 - Sep 2023
1 year 6 monthsQA Manager Qualification/validation
Biopharmaceutical Company
- Review and correction of GMP documents such as qualification documents, technical documentation and risk analyses for various pharmaceutical plants in English
- Preparation of technical documentation for various systems for a pharmaceutical company
Jan 2021 - Jun 2023
1 year 6 monthsLOTO documentation / KSE documentation
pharmaceutical company
- Preparation of technical documentation for various systems for a pharmaceutical company.
- Creation of LOTO-SOP's for plants in the areas of production, infrastructure and warehousing in a pharmaceutical company.
- Preparation of KSE documentation for plants in the areas of production, infrastructure, media and warehouses in a pharmaceutical company.
Jan 2020 - Dec 2021
1 yearvarious activities
Various companies
- Creation and management of interactive training materials (animated videos) / e-learning for a large company.
- Preparation of operating instructions/risk analyses according to MRL for machines and systems in the chemical industry.
- Create LOTO instructions for production, infrastructure, and warehouse assets in a pharmaceutical company.
Jan 2020 - Dec 2020
1 yearvarious activities
Various companies
- Preparation of operating instructions according to MRL Medical technology systems.
- KSE (key safety elements) documentation for a pharmaceutical company.
- Preparation of training materials for pharmaceutical mechanical engineering companies
Jan 2019 - Dec 2020
1 yearvarious activities
Various companies
- Preparation of operating instructions for pharmaceutical packaging systems according to MRL.
- Creation of operating manuals in scheme ST4 for a company in the field of renewable energy.
- Creation of operating manuals for a company in the automotive sector according to MRL.
- Creating LOTO instructions for equipment in a pharmaceutical company.
Jan 2014 - Dec 2019
5 yearsvarious activities
Various companies
- Documentation and creation of SOP ́s for dismantling, assembly and relocation of pharmaceutical plants in Ireland.
- Consulting and report of an OEE analysis of pharmaceutical packaging plants in Ireland.
- Preparation of operating instructions according to MRL for pharmaceutical plants.
- Creation of operating manuals and SOP's in the field of medical technology.
- SOP's for autonomous maintenance and training of plant operators in the pharmaceutical sector.
- Creation of a requirements matrix for the delivery of technical documentation and the review of the delivered documentation from suppliers according to the requirements matrix.
- Risk assessments and SOP ́s for various plants in the pharmaceutical sector.
- LOTO documentation (lockout/tagout) for the entire plant in the pharmaceutical sector
various activities
Various companies
- Similar projects as in the years after for different types of machinery and equipment (see also List of completed projects).
Summary
Mr. Kaske has an exceptionally quick grasp, a broad and deep well of experience, and excellent expertise in qualification and documentation.
In his work, Mr. Kaske stood out in particular for his comprehensive understanding of technically complex issues and kept an overview and a cool head even under high time and success pressure.
Thanks to his very structured, careful, and goal-oriented way of working, he was always able to meet the company’s wishes and requirements correctly and on time.
Overall, Mr. Kaske always performed the tasks assigned to him in every respect to our complete satisfaction.
Mr. Kaske’s personal conduct was at all times impeccable. Because of his expertise, collegiality, and helpfulness, he was respected and popular with supervisors and colleagues.
Languages
German
Native
English
Advanced
Education
Sep 1981 - Jul 1983
Fachschule Für Technik Crailsheim
Advanced Technical College Entrance Qualification · Advanced Technical College Entrance Qualification · Crailsheim, Germany · 1.7
Sep 1981 - Jul 1983
Fachschule Für Technik Crailsheim
State-certified Mechanical Engineering Technician · Mechanical Engineering Technician · Crailsheim, Germany · 1.8
Sep 1975 - Jun 1978
Karl Schaeff Maschinenfabrik
Machinist · Machinist · Langenburg, Germany
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