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Allpack Group (CH)
August 2025 - ongoing
2 qualification projects
  • Commissioning and Qualification of a new blister packaging machine for tablets, incl. creation of all documents
  • Development of new qualification document templates
Ophtapharm Hettlingen (CH)
January - July 2025
Interim department head qualification/validation with management activities
  • Excel Spreadsheet validation
  • Qualification process Redesign and simplification
  • Swiss medic inspection successfully performed and several customer audits
  • Media-Fill / ASP Management responsibility
BGS (Beta-Gamma-Service GmbH & Co. KG) (DE)
​in Cooperation with Coconeo (DE) as sub-contractor
July 2024 - June 2025
Qualification mandate with creation of all live cycle documents for a new process line at a new site incl. FAT execution.
Kantonsspital Winterthur (CH)
​July 2024 - ongoing
  • Standards-based risk analysis for medical compressed air supply and distribution with Gap identification and proposals for risk mitigation actions.
  • Creation of a quality review document of this medical compressed air system from generation, conditioning and distribution
Allpack Group (CH)
April 2024 - December 2024
2 qualification projects
  • Qualification of a new blister packaging and cartoning machine for tablets, incl. creation of all documents
  • Qualification of new display packaging machine with integration into an existing blister & cartoning line, incl. creation of all documents
BioConcept (CH)
March 2024
Review and Update of Supplier Management SOP
Ophtapharm Hettlingen (CH)
July 2023 - December 2024
Qualification coordination and support for a sterile manufacturing site.
  • Q/V of full automated manufacturing systems incl. SW-Updates
  • Qualification reviews
  • specification and qualification of a new lab autoclave
  • requalification activities
  • Excel Spreadsheet validation
  • Qualification System optimization
Früh Verpackungstechnik AG Fehraltorf (CH)
November 2023 - June 2024
CSV - Expert activities
  • Validation of a complete ERP-System using new DevOps solution (main site and new U.S. site) 
  • Support for digitalization activities incl. SOP adaptions
Allpack Group (CH)
​April 2022 - April 2023
6 qualification / validation projects
  • Q&V of a cartoning and serialization machine for tablets, incl. creation of all documents
  • Q&V of new and updated devices of the cartoning and display packaging line for implementation of product serialization / aggregation for China incl. documents
  • CQV of a new Wipotec OCS system (printing and TE labelling) into an existing line incl. documents
  • CQV of a new HAPA late stage customization blister printing machine incl. automated packaging identification devices incl. documents
  • C&Q of a new & retrofit packaging line for solid dosage forms with primary packaging incl. flexo-printing system and secondary packaging machines incl. documents
  • Q&V of new format parts for blisters and bottle filling machines incl. documents
SIS - Medical Frauenfeld (CH)
​Oktober 2021 - January 2022
Creation and revision of basic documents as preparation for a successful NB audit, such as
  • Masterplans
  • Validation master plan matrix
Früh Verpackungstechnik AG Fehraltorf (CH)
​September 2021 - November 2023
  • Creation and revision of SOP's for Audit Trail review process
  • qualification and requalification of several equipment for production and storage purposes
  • Requalification of a Track & trace unit after Software update
  • (successful) FDA inspection support, such as
    • SOP creation and updates
    • validation of a new ERP module incl. URS and RA
    • Updates of several Master Plan ​documents 
Akorn Hettlingen (CH)
February 2021 - December 2022
Qualification coordination and project management and support at a new sterile manufacturing site.
  • SAT of all systems
  • DQ, IQ, OQ and PQ support and execution
  • preparation of all equipment for process validation & media fill activities
Merz Packaging Machines Lich (DE)
January 2020 - July 2020
Development of HDS and SDS documents for a new generation of a stickpack packaging carousel for micro tablets
Allpack Group (CH)
​August 2019 - March 2021
3 requalification / validation Projects
  • Packaging machines for solid dosage forms with secondary packaging and flexo-printing system​
  • process validation of a customer product at a blister packaging line with flexo print unit
Ivers-Lee AG Burgdorf (CH)
May 2019 - May 2022
several qualification and validation Projects
  • 1 stickpack packaging machine upgrade for new products with a new checkweigher and camera inspection system for printed data
  • 1 leak detection system for stickpacks incl. requalification for 2 new inspected products
  • URS, RA , DQ, IQ, OQ and PQ for a new active blister forming and filling machine
  • QMP, RA , DQ, IQ, OQ and PQ for a new stickpack filling  carousel for micro tablets and carousel stickpack inspection machine
  • several dosing units for solid forms (micro tablets)
  • Requalification of a stickpack packaging machine
  • Requalification of a serialization machine after moving
  • Purchase and qualification of a new barcode reading device
  • ​Process validation of two new micro tablet filling processes
  • Project management and Lauch support for an Autoinjector for US and EU / non-EU market release incl. new process specification, process risk analysis and validation acrivities
  • Lab change process for new EU release lab (release testing)
  • transport validation to release lab (IRL) incl. mapping
  • URS creation for a new  Autoinjector Assembling machine, an Autoinjector housing cover machine and a new generation of a carousel leak detection machine 
  • Implementation of two new serialization and aggregation units incl. full life cycle document creation 
  • Light study (document and execution) for a new light sensitive customer product (AI)
Biognosys Schlieren (CH)
​August - September 2019
CSV support
  • Temperature Monitoring support (Gap Analysis)
Früh Verpackungstechnik AG Fehraltorf (CH)
​March 2019 - June 2020
5 Qualification- und Requalification Projects
  • 3 machine upgrades for a new product
  • 2 new camera inspection system for printed data
  • overall Validation plan for implementattion of a new PFS product
Revalidation of a tactile measuring system for 3D measurement of blisters and foils with new GAMP5 compliant software
  • creation of validation plan, protocols and report
  • ​execution of revalidation togeher with the supplier
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