Rüdiger C.

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Binzen, Baden-Württemberg, Germany

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Timeline
About me
Senior QA Manager & CAS QMP
Education
- Hochschule Fresenius Idstein
  2011 - 2013
  Staatsexamen Chemietechniker Fachrichtung Labortechnik 1.8
  Activities and Societies: Job within IFAR Laboratory (Identification of a substance with MALDI-TOF) Additional training for high school degree Additional training for instructor qualification
- Kilian von Steiner Schule Laupheim
  1999 - 2001
  Staatsexamen Umweltschutz-technischer-Assistent 3.0
  Activities and Societies: Globe Project for water analysis of the little river close to the school
- Fachhochschule Nordwestschweiz FHNW
  2020 - 2024
  CAS Quality Manager GMP CAS QMP
  Activities and Societies: Modules with PTS Germany Final thesis with FHNW Muttenz Participation on training courses via PTS:Basic Deviation and CAPABasic FvPBasic GMPBasic HygieneCSV webinarCorrespondence course solid formsExpert ValidationGMP API Expert module 2GMP Audit Expert module 1GMP Basic knowledgeGMP Expert 3 day courseGMP practical trainingGMP Quality ControlMedical Device Regulation seminarRegulatory Affairs compact trainingQuality by DesignFinal Thesis: Hygiene Risk Assessment for Oligonucleotide… Show more Participation on training courses via PTS:Basic Deviation and CAPABasic FvPBasic GMPBasic HygieneCSV webinarCorrespondence course solid formsExpert ValidationGMP API Expert module 2GMP Audit Expert module 1GMP Basic knowledgeGMP Expert 3 day courseGMP practical trainingGMP Quality ControlMedical Device Regulation seminarRegulatory Affairs compact trainingQuality by DesignFinal Thesis: Hygiene Risk Assessment for Oligonucleotide Production Show less
Experience
- Bundeswehr (German Federal Armed Forces)
  Feb 2003 - Aug 2011
  Trainer for preparatory specialist training for the missionsMethod development and validation of analytical methods for pesticides & heavy metals incl. complete documentation.Responsible person for QM documents.Reach back and supply chain management for the missionsParticipant of 3 missions, 23. GECON KFOR (2009, protection force Kosovo)EUFOR RD CONGO (2006, protection force DR Congo) 10. GECON ISAF (2006, protection force Afghanistan). Method development for analysis of chemical warfare agents in water and food
  - Laboratory Technician Method development
    Sept 2004 - Aug 2011
  - Laboratory Technician Method Development
    Feb 2003 - Sept 2004
- Metrohm
  Sept 2011 - Oct 2013
  Laboratory technician IC development
  Performance of ion-analytics with different IC-, column- and detector set ups.Project leader for an accessory kit development project.
- Tillotts Pharma AG
  Dec 2013 - Jan 2022
  Project lead of drug product technical transfer projects, production process or product improvement projects, as well as for API supplier evaluation or process improvement managed by interdisciplinary teams.Contract management for new suppliers for primary packaging, API, as well as CMOs incl. evaluation and negotiation of general terms and conditions.SPOC for the external production (CMOs and API supplier as well as some external labs).Initiation and leading of projects for definition of product specifications for drug substance incl. analytical method development. Cooperation with other project teams involved with product development and implementation of new guidelines, norms and standards. Show less
  - Manager Technical Alliance
    Apr 2018 - Jan 2022
  - Associate Technical Alliance
    Mar 2016 - Mar 2018
  - Laboratory Technician Analytical Development
    Dec 2013 - Mar 2016
- Bachem
  Jan 2022 - now
  - Senior QA Manager
    Jun 2024 - now
  - QA Project Manager
    Jan 2022 - Jun 2024
Licenses & Certifications
- PTS Expert of GMP part 1 & 2
  PTS Training Service
  Sept 2016
- Qualification in daily business (DQ, IQ, OQ & PQ)
  PTS Training Service
  Feb 2015
- Cambridge English Level 2 (Business Vantage)
  Cambridge Assessment English
  Mar 2018
- Technical document acc. MDR 2017/745
  CEplusGmbH
  Apr 2019
- Project management module 1 & 2
  ZfU International Business School
  May 2018
- IMPA Level D
  VZPM - Association for the certification for persons in management.
  Jun 2018