Michael Johner

Michael Johner Email and Phone Number

Owner @ Status-Q
Karlsruhe, BW, DE
Michael Johner's Location
Karlsruhe, Baden-Württemberg, Germany, Germany
Michael Johner's Contact Details

Michael Johner work email

Michael Johner personal email

n/a
About Michael Johner

Interim Management (QP, QA)EU-QP, QP für Klinische Studien, Sachkundige Person, Audits, Lieferantenaudits, Aufbau und Etablierung von QM Systemen für pharmazeutische Unternehmen, Qualitätskontrolle ReinigungsvalidierungSpezialgebiete: Aufbau und Etablierung von QM-Systemen für pharmazeutische Unternehmen, Unterstützung zur Erlangung einer Herstellerlaubnis nach § 13 AMG

Michael Johner's Current Company Details
Status-Q

Status-Q

View
Owner
Karlsruhe, BW, DE
Website:
status-q.eu
Employees:
1
Michael Johner Work Experience Details
  • Status-Q
    Owner
    Status-Q
    Karlsruhe, Bw, De
    View
  • Freelance
    Experte
    Freelance Jan 2022 - Present
    Sachkundige Person für Tierarzneimittel
  • Freelance
    Senior Auditor
    Freelance May 2018 - Present
    Senior Auditor
  • Status-Q
    Owner
    Status-Q Jul 2005 - Present
    Karlsruhe, De
    Interim management, qualified person, cleaning validation, supplier audits, development and establishment of QM systems for pharmaceutical companies, quality control, validation and qualification, QP for clinical studies, communication with authorities (in Germany), responsible person for narcotic substances according to German drug law, perception of AMG (German drug law) functions, troubleshooting
    View
  • Health Logistics Gmbh
    Qualified Person, Head Of Quality Control
    Health Logistics Gmbh Apr 2006 - Present
    QP, QC, QA
  • Emergent Biosolutions
    Head Of Manufacturing
    Emergent Biosolutions 2010 - Present
    Gaithersburg, Maryland, Us
    Leiter QM und Leiter Herstellung
    View
  • Nemera
    Gruppenleiter Qualität Apu 1
    Nemera Feb 2023 - Aug 2023
    Lyon, Auvergne-Rhône-Alpes, Fr
    View
  • Nemera
    Leiter Qualität
    Nemera Jul 2020 - May 2021
    Lyon, Auvergne-Rhône-Alpes, Fr
    View
  • Mickan Arzneimittel Gmbh
    Qualified Person, Head Of Qc, Head Of Qa, Qppv, Information Officer
    Mickan Arzneimittel Gmbh Sep 2005 - Dec 2020
    Filling and release of herbal drugs, supplier qualification, audits, head of quality control, quality assurance and qualified person, drug safety officer
  • Hersteller Von Pflanzlichen Arzneimitteln
    Sachkundige Person, Qs-Beratung
    Hersteller Von Pflanzlichen Arzneimitteln Mar 2015 - Mar 2019
    Qualified person for herbal liquid, semi-solid and solid products; preparation and performance of inspection of chinese authorities (C-FDA), cleaning validation (planning and report), supplier audits (Spain, Germany), requalification of equipment, improvement of quality assurance
  • Spenglersan Gmbh
    Head Of Qa, Deputy Qp, Deputy Head Of Qc
    Spenglersan Gmbh Jun 2008 - May 2016
    Quality Assurance, Manufacturing, Validation and Qualification, Quality Control
  • Supracell
    Qualified Person, Head Of Qa, Head Of Qc, Drug Safety Officer, Information Officer
    Supracell Jul 2005 - Jun 2015
    Sachkundige Person, Leiter Qualitätskontrolle, Leiter QM, Informationsbeauftragter, Stufenplanbeauftragter
  • Herbrand Pharmachemicals
    Qa Interim Manager
    Herbrand Pharmachemicals Nov 2014 - Jan 2015
    Qualifizierung, Reinigungsvalidierung
  • Jäger Gmbh
    Qualified Person, Director Qc
    Jäger Gmbh Sep 2012 - Feb 2014
    QP, QC
  • Impstoffhersteller (Schweiz)
    Interim Manager Capa Management
    Impstoffhersteller (Schweiz) Jan 2012 - Sep 2012
    Remediation of CAPA backlog
  • Actavis Deutschland Gmbh & Co. Kg
    Deputy Qp, Head Of Qa, Remediation Of Qa Various Issues
    Actavis Deutschland Gmbh & Co. Kg Mar 2011 - Dec 2011
    Remediation of various QA issues in close contact with responsible authorities, renewal of manufacturing license
  • Zag Zyklotron Ag
    Qualified Person
    Zag Zyklotron Ag Nov 2006 - Apr 2009
    Manufacturing of radioactive injectables
  • Iwk Verpackungstechnik
    Head Of Validation/Qualification, Head Of Technical Documentation
    Iwk Verpackungstechnik Oct 2002 - Jun 2005
    Project management, qualification, commissioning and qualification, technical documentation
  • Klocke Verpackungs-Service Gmbh
    Head Of Manufacturing, Head Of Qc, Head Of Qa
    Klocke Verpackungs-Service Gmbh Jan 1993 - Sep 2002
    QA, QP, QC, project management, compliance, clinical study supply, qualification, validation, SAP implementation (QC), 21 CFR 11, auditor
  • Albert-Ludwigs-University Freiburg I. Breisgau, Germany
    Scientific Employee, Safety Offier
    Albert-Ludwigs-University Freiburg I. Breisgau, Germany Nov 1987 - Oct 1992
    Supervision of students in the 1st and 3rd semesters, instruction of trainees, safety officer in the chemical laboratory for organic chemistry, seminars in organic chemistry and chemical nomenclature

Michael Johner Skills

Validation Capa Pharmaindustrie Gmp Gute Laborpraxis Quality Assurance Sop Technologietransfer Pharmaceutical Industry Klinische Studien Quality System Qa Quality Control Biowissenschaften Medizinprodukte Glp Freelancer Capa Reduction Quality Auditing Quality Management Technology Transfer Fda Life Sciences

Michael Johner Education Details

  • Pharmazeutisches Institut Der Albert-Ludwigs-Universität Freiburg
    Pharmazeutisches Institut Der Albert-Ludwigs-Universität Freiburg
    Pharmazeutische Chemie
  • The University Of Freiburg
    The University Of Freiburg
    Studies Of Pharmacy (1982-1987) With License To Practice (Approbation)

Frequently Asked Questions about Michael Johner

What company does Michael Johner work for?

Michael Johner works for Status-Q

What is Michael Johner's role at the current company?

Michael Johner's current role is Owner.

What is Michael Johner's email address?

Michael Johner's email address is mi****@****us-q.de

What schools did Michael Johner attend?

Michael Johner attended Pharmazeutisches Institut Der Albert-Ludwigs-Universität Freiburg, The University Of Freiburg.

What skills is Michael Johner known for?

Michael Johner has skills like Validation, Capa, Pharmaindustrie, Gmp, Gute Laborpraxis, Quality Assurance, Sop, Technologietransfer, Pharmaceutical Industry, Klinische Studien, Quality System, Qa.

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