Dr. Franz Köhler Chemie GmbH | Germany | 64xxx Alsbach-Hähnlein | Permanent position | Full time / Home office | Published since: 03.02.2026 on stepstone.de
Employee Quality Assurance / CAPA Management and Non-Conformities (m/f/d)
We have been for you for three generations. As a family-run pharmaceutical company, we combine tradition and responsibility. With around 270 dedicated employees developing, producing and distributing our products –“Made in Germany” with a strong reputation for quality and reliability. Our products have a high clinical relevance, especially in the areas of cardiac surgery, intensive care and emergency medicine, and are used in clinics with the aim of “protecting and improving life”. Our motto “We for you” describes what drives us – responsibility for patients, our partners and customers, and respectful handling within our team. Become part of our success story – we look forward to you!
Quality Management / CAPA Management and Non-Conformities (m/w/d)
* After clicking the Read more button, the original advert will open on our partner's website, where you can see the details of this vacancy and contact information. If you need a translation of this text, after returning to our website it will be prepared and you can read it by clicking the Show full translation button.
Your tasks • Your profile • What we offer
Processing and acquisition of independent projects to optimize existing processes and processes Creation and processing of SOPs concerning non-conformities (OOS/deviation management) and corrective and preventive actions (CAPA management) Support in creating and evaluating deviations and CAPAs Support in carrying out Cause Analysis in the context of Deviation or CAPA Processes Support in the processing and evaluation of temperature deviations during transport (reclamation management) Master data maintenance in electronic systems Evaluation of quality assurance processes with regard to performance indicators Presentation of the topics of the department in authority inspections In case of need, support of complaint management o.
Successfully completed university studies in the field of pharmacy, biology, chemistry, biotechnology, pharmaceutical technology and comparable engineering studies (required) - Alternative a long-term relevant professional experience in the above-mentioned field of work Experience in pharmaceutical production / in the GMP environment Experience in GMP-compliant creation of documents (deviations/ CAPAs, causes analyses according to 5-why or Ishikawa, risk analyses, SOPs) Good knowledge of the current EU and FDA GMP regulations, AMWHV and AMG Very good German knowledge (word/writing) Good knowledge of English (word/writing) Impressed communication and organisational capability and a structured functioning High sense of responsibility and quality
Friendly colleagues Small teams Good work-life balance Attractive remuneration Occupational pension and supplementary health insurance Flat hierarchies Space for ideas, initiative and design Homeoffice (partly possible) Good training opportunities Modern jobs Free coffee and water Food grant for Freshtaste Fridge Corporate Benefits On-site parking
Location
 | Dr. Franz Köhler Chemie GmbH | |
| 64665 Alsbach-Hähnlein | ||
| Germany |
The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.
For more information read the original ad