Qualification Expert

Vor 5 Tagen

Kaiseraugst, Schweiz FLEXSIS Vollzeit

**INTRODUCTION**:
As a preferred supplier for Roche Basel in Kaiseraugst, we are looking for an individual

**Qualification Expert**:
This is a full-time position (100%) with a 12-month contract. The ideal start date is asap. Home Office is possible up to 20%.

**ASSIGNMENT DESCRIPTION**:

- Responsible for planning and conducting qualification and validation activities
- Creating and reviewing qualification and validation documents
- Producing SOPs and providing support in the creation of manufacturing specifications
- Responsible for maintaining the qualified and validated status of rooms, infrastructure and equipment
- Ensuring compliance with internal and external regulatory requirements with regard to qualification and validation
- Collaborating closely and communicating intensively with other departments
- Providing assistance in the processing of deviations, changes and CAPAs

**REQUIRED PROFILE**:

- Technical degree in a relevant field
- Further training and hands-on experience in the area of GMP
- Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
- Several years hands on work experience in qualification
- Experience with Siemens COMOS, EVAL and VIVA
- Fluency in German spoken and written needed, English fluency written and reading comprehension
- Very independent and structured way of working with a self-image of self and to continuously improve the processes
- High degree of initiative, flexibility and quick comprehension skills
- Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture

**Application process**:
Interested? You can find more information here:

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