Seeking a dedicated Quality Assurance Architect to join our team in Bern. In this role, you will play a crucial part in the creation and implementation of the aseptic operator training program. Your responsibilities will include:

• Developing and updating procedures and risk assessments to ensure compliance with global procedures and standards.
• Creating Standard Operating Procedures (SOPs) in areas such as microbiology, hygiene, aseptic behavior, transitional spaces, and gowning procedures.
• Training operators on aseptic processes and manufacturing protocols, ensuring a deep understanding of microbiology, hygiene, and aseptic behavior.
• Supporting Annex 1 gap mitigation and remediation in collaboration with the manufacturing department, including the creation of work instructions, risk assessments, and process design.

Qualifications:

• Language Requirements: Proficiency in German and English (Business Level).
• Education: Degree in Life Sciences.
• Experience:
  • Strong technical knowledge in sterility assurance of aseptic cleanroom facilities, including processes, equipment, and personnel management, with a focus on design, use, and life cycle management in compliance with cGMP.
  • Previous experience in the pharmaceutical manufacturing industry, specifically in aseptic processing.
  • Demonstrated experience in quality assurance and regulatory compliance, particularly with EU GMP Annex.

If you are passionate about quality assurance in aseptic processes and meet the above qualifications, we encourage you to apply and be a part of our mission to deliver life-saving therapies.