About us
SCHOTT's Business Unit Pharmaceutical Systems is a leading manufacturer of pharmaceutical primary packaging and analytical lab services.
With over 600 production lines in 13 countries worldwide, we produce more than 10 billion syringes, vials, ampoules, cartridges, and special articles of tubing glass or polymer every year.
Your Contribution
1. You are a result-driven professional with the ability to balance the dynamics of a development environment and the diligence required for quality management processes.
2. You will maintain and develop our Research and Development Quality Management System (QMS) to ensure compliance with regulatory requirements.
3. You will manage the R&D Corrective Action Preventative Action (CAPA) process and perform internal audits according to ISO 15378 and ISO 13485 standards.
4. You will drive continuous improvement within R&D and its interfaces, promoting efficient and effective processes.
5. You will ensure that all development documentation is compliant and harmonized.
6. You will provide guidance and training to your colleagues to ensure they understand and adhere to our QMS.
Your Profile
7. You hold a University degree in Engineering, Life Science, or a related field.
8. You have at least 3 years of working experience in the pharmaceutical packaging, medical device, or pharma industry, with a background in development environments and contact with QMS according to ISO 15378 or ISO 13485 or similar.
9. You possess strong organizational skills, are proactive, and work independently with diligence.
10. You have knowledge in QMS and document management, as well as Good Document Practice (GDocP).
11. You have excellent presentation and moderation skills, with a focus on accuracy and attention to detail.
12. You have experience participating in or leading audits, preferably certified in ISO 13485 / ISO 15378.
13. You possess excellent interpersonal and communication skills, with fluency in English and German.
Your Benefits
We offer a unique corporate culture that emphasizes equity, diversity, and inclusion. We believe that motivated and committed employees are essential to our company's success.
You can expect interesting tasks, challenging projects, and a supportive team in fields that shape our future.