Quality Assurance Specialist - Quality System (x|w|m) - On-site

Be prepared to start our new, modern production site and fill it with life. For Quality Assurance within Sartorius CellGenix GmbH we are looking for a Quality Assurance Specialist - Quality System (x|w|m). In this position, you are responsible for the processing and testing of quality assurance measures taking into account GMP and ISO 9001 regulations, internal standards and group specifications.

The job is full-time and takes place on site at our location in Freiburg, our competence center for the development and production of cell culture components.

You support the maintenance and further development of the quality management system with deviation management, CAPA, change control and complaint management

You maintain and manage the system for the training and qualification of employees

You conduct training on the quality management system

You plan to carry out and reprocess customer, TÜV and internal audits on site

You support in preparing management reviews and providing quality indicators

You are responsible for the maintenance and management of the electronic document and quality management system

You process the integration of new regulatory or group requirements into the existing QMS processes

You participate in risk analysis to identify and minimize potential vulnerabilities in the quality management system

You have a degree in the field of pharmacy, natural sciences or a comparable qualification

Multiannual professional experience in quality assurance in the GMP/ISO 9001 environment, preferably in the pharmaceutical industry

The qualification as an auditor is advantageous as well as experience in the planning and implementation of audits

Ideally, you have first experience in handling electronic document management and quality management systems

Very good knowledge of EU GMP regulations and ISO 9001

German and very good English knowledge in word and writing as well as pronounced communication skills

You are characterised by an independent, solution-oriented approach and enjoy the implementation of improvements

You identify with our values sustainability, openness & joy and are motivated to work in a fast growing company

As a globally growing life science company listed in the DAX and TecDAX, Sartorius offers a variety of advantages: Room for your personal and professional development: mentoring, leadership programs, talent talks, internal seminar offer

From the outset: Comprehensive onboarding including online platform – even before entry, workshops, “Buddy” as a contact person or person. Contact person

Internal networking: Communities on numerous topics such as coaching, agile work and yoga, Business Women Network

Successful company on growth course: permanent employment contract, 30 days per year and a 40h week inclusive flexible working time with sliding time and contribution to the occupational retirement provision

Well-Being: Free drinks (coffee, tea and water) as well as attractive corporate fitness offers

Mobility benefits: Good access to public transport and free parking

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