summary

12 months+, schaffhausen
temporary

job category
other

job details

Johnson & Johnson manufactures pharmaceutical and medical devices as well as active pharmaceutical ingredients (APIs) for the global markets at its production site in Schaffhausen. Thanks to our innovative products, processes and technologies, Johnson & Johnson is now one of the leading pharmaceutical companies in Switzerland and the Schaffhausen site is also a strategic launch and growth location

If you are enthusiastic about ensuring patient safety by verifying the qualified state of our lab equipment through AIQ periodic reviews and if you are interested in leading innovative the automatization of such review processes, this might be an interesting opportunity for you.

Key Responsibilities:

Planning, coordination, and timely execution of the AIQ periodic review, coordinating necessary activities with the QC laboratories.
Leading the roll-out of the new HELPr tool in close collaboration with the global ELM CoE Presentation of the AIQ periodic review process during regulatory inspections and customer audits.
Creation and maintenance of standard operating procedures, training of employees within the area of responsibility.
Execution of system audit trail reviews for laboratory equipment.
Participation in the creation and processing of non-conformances and change requests in Comet, as well as assisting in the definition of corrective and preventive actions (CAPA).

Caring for the world ... starting with the individual. This guiding principle inspires and unites the people at Johnson & Johnson. The culture of caring is at the heart of our corporate philosophy, which is anchored in our Credo.

Johnson & Johnson manufactures pharmaceutical and medical devices as well as active pharmaceutical ingredients (APIs) for the global markets at its production site in Schaffhausen. Thanks to our innovative products, processes and technologies, Johnson & Johnson is now one of the leading pharmaceutical companies in Switzerland and the Schaffhausen site is also a strategic launch and growth location

Key Responsibilities: ...

Planning, coordination, and timely execution of the AIQ periodic review, coordinating necessary activities with the QC laboratories.
Leading the roll-out of the new HELPr tool in close collaboration with the global ELM CoE Presentation of the AIQ periodic review process during regulatory inspections and customer audits.
Creation and maintenance of standard operating procedures, training of employees within the area of responsibility.
Execution of system audit trail reviews for laboratory equipment.
Participation in the creation and processing of non-conformances and change requests in Comet, as well as assisting in the definition of corrective and preventive actions (CAPA).

qualifications
- Successfully completed a degree in a scientific or technological field, preferably with a focus on pharmaceuticals, chemistry, or biotechnology, or relevant experience as a chemistry or biology laboratory technician in quality control, preferably in a GMP-regulated environment.
- Excellent organizational and communication skills, customer-oriented work approach, and a "can-do" mentality.
- Very good knowledge of Microsoft Office programs (Outlook, Word, Excel, PowerPoint).
- Experience in reviewing analytical data and GMP documents, as well as experience with SAP and Comet, is beneficial.
- Fluent in German and English (spoken and written).

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