Quality Assurance Architect (m/f/d)

Ihre Aufgaben:
• Supports implementation of the aseptic Isolator Filling Line
• Creation and update of procedures, risk assessments, concepts

• Ensureses adherence to global procedures and standards

• Supports creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process
• Supports creation of aseptic process validation reports, protocols and procedures

Ihre Qualifikationen:
• Degree in Life Sciences e.g. Biology, Chemistry or Pharmacy
• 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
• Well-founded experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
• Extensive professional experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning

• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines
• Business level language skills in German and English

Ihre Vorteile:
• A very renowned company

• Modern company spirit and modern working environment

• Good chances of a permanent position

• A highly motivated team and an open way of communication

Projektdauer: 12 MM


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