Quality Assurance Architect
Location: Bern
Start Date: January 12, 2024
End Date: June 30, 2025
Job Title: Quality Assurance Architect
Job Description:
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.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
Equal Employment Opportunity
It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.