Quality Assurance Specialist – Sterility Assurance (5309 – ADA)

 

Our client, a large pharmaceutical organization, is looking for a German speaking Quality Assurance Specialist (Sterility Assurance) for a 12-month contract (with a possibility of extension) in Bern to support the creation and implementation of Aseptic Operator training program.

 

Main responsibilities:

  • Supports creation and implementation of the aseptic operator training program for the client’s site in Bern
  • Creation and update of procedures, risk assessments, concepts
  • Ensureses adherence to global procedures and standards of the client
  • 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 (Virtual Training) technology for aseptic operator training

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • 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 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.
  • Background in Sterility Assurance, Sterile Manufacturing, Quality on the floor or similar would be highly preferred

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