Experience

Helixor Heilmittel GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head Of Production

  • Jun 2020 - Present

  Head of production for Steriles and Packaging:• Initiation of workflows (GMP)• Media fill• Quality Oversight• Deviations• Preventive and corretive actions• Change management• SOPs and working instructions• Complaints• Inspections of suppliers • Representer of production unit (internation / external inspection and visitor groups) Head of production for Steriles and Packaging:• Initiation of workflows (GMP)• Media fill• Quality Oversight• Deviations• Preventive and corretive actions• Change management• SOPs and working instructions• Complaints• Inspections of suppliers • Representer of production unit (internation / external inspection and visitor groups)



Takeda in Deutschland

• Germany
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Manufacturing Specialist Vaccines

  • Jul 2018 - May 2020

  New production site for vaccines:• Project phase (FAT, Qualifiation, Training)• Tech transfer New production site for vaccines:• Project phase (FAT, Qualifiation, Training)• Tech transfer



Novartis Pharma Produktions GmbH

• Process Expert, Solids

  • Aug 2016 - Jun 2018

  • Deviation management, investigation lead and support during complaint investigation • Specification, implementation and monitoring of Corrective Actions and Preventive Actions (CAPAs) including Effectiveness Check • Specialist resonsibility GxP and HSE requirements• Process Optimization• Project Management • Head of Manufacturing • Presentation of the production area in internal and external inspections • Support of qualification and validation activities• First point of contact for manufacturing issues



Testo Industrial Services DE

• Germany
• Industrial Machinery Manufacturing
• 200 - 300 Employee

• Qualification engineer

  • Mar 2014 - Jun 2016

  • Preparation of User Requirements Specification • Preparation and implementation of Qualification documentation of different equipment and new plants in the manufacturing and packaging area due to guidelines and directives • Preparation and implementation of technical changes at plants and rooms • Preparation of Risk Analysis• Preparation of Standard Operation Procedures (SOPs); Training of the operator • Preparation of User Requirements Specification • Preparation and implementation of Qualification documentation of different equipment and new plants in the manufacturing and packaging area due to guidelines and directives • Preparation and implementation of technical changes at plants and rooms • Preparation of Risk Analysis• Preparation of Standard Operation Procedures (SOPs); Training of the operator