We are looking for an independent personality with a passion for Quality Assurance.
Reporting to the Director of Quality Management & Regulatory Affairs, you will be responsible for harmonizing our global quality management systems.
Your main tasks
- Developing and implementing QMS improvements of our clients
- Writing of Global Quality Standards
- Ensure complied documentation systems of our clients
- Ensure compliance with product realization processes
- Conception and Implementation of Supplier Quality Agreements
- Supplier and Internal Audits including Mock-Inspections
- Planning and moderation of QA workshops and training events
- Support tech transfer and analytical method transfer activities
- Support and consulting R&D and product management team in the interpretation of regulatory requirements
- Deputy of Director QM/RA
- Process owner «Doc Control», «Audit Management», « Knowledge Management» and «Process Management».
What we offer you
- Dynamic, exciting, and challenging work environment with plenty of room to contribute, shape and influence the future development of the Group.
- International work environment with a global customer base.
- Collaboration in a dynamic, open-minded team
- Possibility to work in home office
- In-house restaurant for the employees serving freshly prepared lunch
In this role within an international, world-renowned company, you will enjoy a high degree of flexibility and be able to make a decisive contribution to the realisation of the corporate vision. With its unique safety concept regarding the temperature monitoring of pharmaceutical products, Berlinger plays a significant role to always ensure impeccable quality. In addition to the modern and familiar working environment, a job at Berlinger impresses with this profound sense of purpose in the business field. Add a substantial part to ensure the high quality and development of the company in the future.
Extensive familiarisation with the new tasks and projects will prepare you optimally for your new field of activity. Take the opportunity to become part of our innovative Berlinger team and make your contribution to our road to success.
It was a great honour for us to receive the Switzerland Global Enterprise Export Award 2020. Berlinger convinced the jurors with our internationalization strategy, based on careful market analyses, the cultivation of worldwide partnerships and a clever growth strategy.
- University degree in Quality, Engineering, Sciences or another relevant discipline
- At least 2-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medi-cal Devices industry
- Broad working knowledge of Quality Management Systems, cGMP and ICH Q9 regulations; basic understanding of manufacturing and supplier process
- Analytical and structured working style; strong attention to detail
- Ability to effectively work as part of a multidisciplinary, international team
- Fluent in German and English (written and spoken)
- Proactive team player with "can do" mentality
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