For our client, a global company in the field of biotherapy, we are looking for a

Quality Assurance Architect (m/f/d) 100%
Tasks & Responsibilities:

• 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

Must Haves:

• Bachelor's degree in Life Sciences (*****)
• 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 (*****)
• +5 years of 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
• Background in Sterility Assurance, sterile manufacturing, quality on the floor, aseptich operator training, aseptic process validation (Media Fill) is preferred
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines. (*****)
• Fluent in English and German (*****)

General Information:

• Start date: 13.05.2024
• End date: 1 year
• Work location: Bern
• Remote/Home Office: Possible but some on-site required
• Workload: 100%

Your Application: Please apply online. For further information about the position, please contact your Kelly recruiter, Fatbardha Igrishta (fatbardha.igrishta[a]kellyservices.ch).