Michél Hellmann Email & Phone Number

Marburg, Hessen, Deutschland

Operational QA Manager at PU MVV/CSS at Marburg Site

Marburg, Hessen, Deutschland

Operational Compliance Support of Vaccine Production against Rabies, TBE and Mumps as well as Adjuvants, Media and production equipment.Lead of the GMP Compliance Support Deviations Group of the Process Unit (CSS/MVV) for production of Rabies, TBE and Mumps antigen and for the production of media, adjuvants and production equipment. Fields of activity of the group:- Deviation Management Process - Investigation of all deviations, including critical ones -… Show more Operational Compliance Support of Vaccine Production against Rabies, TBE and Mumps as well as Adjuvants, Media and production equipment.Lead of the GMP Compliance Support Deviations Group of the Process Unit (CSS/MVV) for production of Rabies, TBE and Mumps antigen and for the production of media, adjuvants and production equipment. Fields of activity of the group:- Deviation Management Process - Investigation of all deviations, including critical ones - assessment of potential product impact, incl. filing of BPDRs (if necessary) - proposals for lot dispositions - definition and implementation of corrective actions - cont. development of deviation process - complaints- Continuous inspection readiness - preparation and execution of inspections by health authorities, e.g. FDA, ANVISA, MFDS, RP PEI, etc. - Continuous Process Improvement - keep cGMP status, implementation of upcoming USP and Ph.Eur. requirements - CI CAPA definition and implementation - support increase of production efficacy - harmonization of standards and procedures- KPIs and Reporting- Establishment of APRs Show less

Marburg

Lead of the GMP Compliance Support Team supporting Rabies Vaccine production and deputy manager of the whole compliance support team supporting the rabies, TBE and Mumps vaccine production. Fields of activity of the group:Investigation of deviations, including critical deviations, assessment of potential product impact, proposals lot dispositions; CAPA definition and implementation; Change Control Requests, Document Management; Continuous Process Improvement, KPIs and Reporting… Show more Lead of the GMP Compliance Support Team supporting Rabies Vaccine production and deputy manager of the whole compliance support team supporting the rabies, TBE and Mumps vaccine production. Fields of activity of the group:Investigation of deviations, including critical deviations, assessment of potential product impact, proposals lot dispositions; CAPA definition and implementation; Change Control Requests, Document Management; Continuous Process Improvement, KPIs and Reporting , Establishment of APRs and preparation of inspections by health authorities, e.g. FDA, PEI etc. Show less

Marburg

Fachliche Führung der GMP Compliance Support Gruppe:Tätigkeitsfeld der Gruppe: Bearbeiten von Abweichungsmeldungen, inkl. critical investigations und Bewertung des Produkteinflusses, CAPA Implementierung, Change Request, Dokumentenmanagement, Continuous Process Improvement, KPIs, APRs und Vorbereitung behördlicher Inspektionen (FDA und PEI)

Marburg

Fachliche Führung der GMP Compliance Support Gruppe:Tätigkeitsfeld der Gruppe: Bearbeiten von Abweichungsmeldungen, inkl. critical investigations und Bewertung des Produkteinflusses, CAPA Implementierung, Change Request, Dokumentenmanagement, Continuous Process Improvement, KPIs, APRs und Vorbereitung behördlicher Inspektionen (FDA und PEI)

Marburg

Produktionssupport im GMP Umfeld, Bearbeiten von Abweichungsmeldungen, inkl. critical investigations und Bewertung des Produkteinflusses, CAPA Implementierung, Change Request, Dokumentenmanagement, Continuous Process Improvement, KPIs, APRs und Vorbereitung behördlicher Inspektionen (FDA und PEI)

Wildau

Im Rahmen folgender FuE-Projekte als wissenschaftlicher Mitarbeiter an der TH Wildau beschäftigt:Planung, Realisierung und Validierung einer integrierten Pilotanlage zur Bereitstellung von Energie und nachwachsenden Rohstoffen aus Algen bestehend aus Photobioreaktoren, BHKW und Anaerobanlage. Entwicklung eines Verfahrens zur Vor-Ort-Detektion von Cyanobakterientoxinen.Verfahrensentwicklung zur Produktion enantiomerenreiner Diole mittels Biotransformation.