Mads Kalum Heman Email & Phone Number | Total of 8 years experience within pharmaceutical industry working with aseptic production with a wide range of areas of expertise. Current work area: Validation and qualification of Equipment/Computerized Equipment and processes according to science and risk based concept and in compliance with EudraLex Annex 15. (Requirements setting, configuration control, change control etc.) Ensuring high level of quality throughout global innovation projects within Aseptic production areas utilizing Quality Management, ISO 9001 and ISO 10006. Creating an maintaining design, qualification and validation documents eg. Validation planning, protocols and reports (DQP/R, IOVP/R, IOQP/R etc.) Areas of expertise: - Validation and Qualification of Equipment/Computerized Equipment and Processes - Quality Risk Management (QRM) - Aseptic production (Filling and Wash & Sterilization) - Change control, Deviations, Systematic problem solving (cLEAN)

Mads Kalum Heman

Total of 8 years experience within pharmaceutical industry working with aseptic production with a wi...
Denmark

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Mads Kalum Heman’s Email hemanm@novonordisk.com

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Mads Kalum Heman’s Location Denmark

Mads Kalum Heman’s Current Industry Novo Nordisk

Mads Kalum Heman’s Prior Industry Process Design | Haldor Topsoe

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Senior Validation Engineer

2024-06-01 00:00:00 - Present

Chemical Engineer

2019-06-01 00:00:00 - 2019-11-01 00:00:00

Intern

2017-02-01 00:00:00 - 2017-06-01 00:00:00

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Mads Kalum Heman is a Total of 8 years experience within pharmaceutical industry working with aseptic production with a wide range of areas of expertise. Current work area: Validation and qualification of Equipment/Computerized Equipment and processes according to science and risk based concept and in compliance with EudraLex Annex 15. (Requirements setting, configuration control, change control etc.) Ensuring high level of quality throughout global innovation projects within Aseptic production areas utilizing Quality Management, ISO 9001 and ISO 10006. Creating an maintaining design, qualification and validation documents eg. Validation planning, protocols and reports (DQP/R, IOVP/R, IOQP/R etc.) Areas of expertise: - Validation and Qualification of Equipment/Computerized Equipment and Processes - Quality Risk Management (QRM) - Aseptic production (Filling and Wash & Sterilization) - Change control, Deviations, Systematic problem solving (cLEAN) - PAS-X (GMBR, PMBR, PVL, EBR)