Quality Assurance Architect 20622-1

Vor 3 Tagen

Bern, Schweiz We make it GmbH Vollzeit

We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for quality, ethics and discretion.

For our client, a renowned pharmaceutical company based in Bern, we are looking for an Quality Assurance Architect (M/F/d)

Quality Assurance Architect 20622-1 (M/F/d)

Background

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

Tasks
- Supports creation and implementation of the aseptic operator training program for the CSL Behring site Bern
- Creation and update of procedures, risk assessments, concepts
- Ensureses adherence to global CSL procedures and standards
- Creation of training content in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Implementation of state of the art VR technology for aseptic operator training
- \+5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
- Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning and utilities
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
- Looking for background in Sterility Assurance, sterile manufacturing, quality on the floor or similar

**Requirements**:

- Language: German and English Business Level
- Education: Degree in Life Sciences
- Experience:
Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.

Work hours
- 41 h / Standard

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