Dr. Dirk Badura

System owner of the worldwide used QMS Software of CHAM

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.

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.

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.

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

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)

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)