Lothar Kaske

QA Manager GMP / SOP Author / Training Documentation

04/2026-

QA Manager GMP at a pharmaceutical company

8/2025-03/2026

• Creation of machine assessments in accordance with ISO 12100 / BetrSichV for 2 large pharmaceutical packaging plants for a Sanofi facility.

01/2025-09/2025

• Creation of a new structure and pilot creation of training materials for various machines for the pharmaceutical industry with learning objectives, learning content, and learning success control.

• QA Manager biopharmaceutical company

Review and correction of GMP documents such as qualification documents DQ, IQ, OQ and PQ, technical documentation, CAPA's, deviations, and risk analyses for various pharmaceutical plants in English. (See also appraisal Curevac)

10/2023-02/2024

• Creation of KSE and LOTO SOPs for plants in the areas of liquid and solid production, liquid and solid packaging, infrastructure (HVAC, CIP/SIP, media), laboratory, and warehouse in a pharmaceutical company.

• QA Manager biopharmaceutical company

Review and correction of GMP documents such as qualification documents, technical documentation, and risk analyses for various pharmaceutical plants in English

• Creation of technical documentation for various plants for a

2021

• Creation and management of interactive training materials (animated videos) / e-learning for a large company.

2020

• Creation of operating instructions according to MRL medical device regulations

• KSE documentation (key safety elements) for a pharmaceutical company

• Creation of training materials for pharmaceutical mechanical engineering companies

2019

• Creation of operating instructions in Schema ST4 for a company in the renewable energy sector

2014-2018

• Documentation and creation of SOPs for dismantling, assembly, and relocation of pharmaceutical plants in Ireland.

• Consulting and reporting of an OEE analysis of pharmaceutical packaging plants in Ireland.