Dr. Dirk Badura

Basic

Angestellt, Senior Head of Quality & ESH, Carbogen Amcis AG

Bubendorf, Switzerland

Skills

Leadership
Analytical Chemist (PhD)
Transaktionsanalyse
Broad QC Experience (since 2001)
Project Management
Process-Optimisation
QA-Experience (Since 2011)
LIMS
CDS
Document Management
Management Handbook
Lieferantenmanagement
Computer System Validation
Auditor
Audithost
GMP Qualification Validation
Qualitätskontrolle

Timeline

Professional experience for Dirk Badura

  • Current 8 years and 1 month, since Jun 2014

    Senior Head of Quality & ESH

    Carbogen Amcis AG

    Leading the Quality and ESH unit of CARBOGEN AMCIS consisting of the Departments Project Quality Assurance, Quality Systems, Regulatory Affairs, Quality Control & Analytics and Environment, Security & Health of the Swiss sites of CARBOGEN AMCIS.

  • 3 years and 2 months, Apr 2011 - May 2014

    Head of Quality System

    Carbogen Amcis AG

    Responsible for all "non-project/product" but systemic aspects in Quality Assurance: Management Hand-book, Training, Cleaning, Equipment Qualification and Maintenance, Monitoring activities (pest control, temperature, water, MiBi), Archives, Document Management, IT Qualification and Life Cycle and Audits (authorities, customer, internal and vendors). Leading a team of 5 employees.

  • 3 years, Apr 2008 - Mar 2011

    Head System Management

    CARBOGEN AMCIS AG

    Support of system owner, IT and QA regarding Evaluation, Qualification, Project Managment and Life Cycle of computerized systems like LIMS, CDS and more. Project manager in several internal projects regarding optimizing internal processes, harminoisation of the site specific processes.

  • 3 years and 4 months, Dec 2004 - Mar 2008

    Deputy Head Quality Control

    CARBOGEN AMCIS AG

    Release of all kinds of raw materials and intermediates. Co-Managing a group with four subgroups (QC Lab 1 and QC Lab 2, stability & validation group, sampling group). Writining of stability & validation plan and reports, SOPs and method descriptions

  • 3 years and 5 months, Jul 2001 - Nov 2004

    Head of Analytics and Quality control

    ChemCon GmbH

    Setup of the analytical department. Started with 2 HPLCs and an IR-spectrometer and no coworkers in 2001. Ending with a set of SOPs for quality control for a company working under full GMP, 4 Coworkers and a set of all instruments needed (e. g. HPLC, GC, Titration, IR, NMR, UV, Polarimeter) in 2004. Responsible for all analytical and quality control (method development 1 validation, release of raw mat., intermediats and final products, stability studies, qualification + life cylce of instruments)

Educational background for Dirk Badura

  • 10 years and 10 months, Oct 1990 - Jul 2001

    Chemie

    Albert-Ludwigs Universität Freiburg i. Brsg.

    Theses performed at the institute for analytical and inorganic chemistry in the work group of Prof. Vahrenkamp in his bioionorganic research field (molecular complexes of zinc with nucelobases)

Languages

  • German

    First language

  • English

    Fluent

  • French

    Basic

Wants

Networking
Erfahrungsaustausch
Informationsaustausch
Nette Menschen

Interests

Cycling
Football/Soccer
Webdesign/Homepage

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