Hybrid Sterility Assurance Expert

Posted 2 weeks ago

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About the role

  • Expert Sterility Assurance for sterile drug production in Wasserburg am Inn. Ensuring compliance with aseptic processes and overseeing quality activities in sterile production.

Responsibilities

  • Develop templates for establishing, maintaining and optimizing aseptic processes within cleanrooms and filling lines across all manufacturing-relevant activities
  • Advise departments on validation and revalidation of microbiological monitoring, including but not limited to HVAC, autoclaving processes, VHP fumigation, depyrogenation and CIP/SIP
  • Conduct relevant personnel training
  • Perform quality oversight for the conduct of media fills and support their evaluation, including preparation and maintenance of documentation
  • Take responsibility for establishing, monitoring and training on the hygiene and disinfection concept in sterile production facilities
  • Independently monitor processes to ensure sterility and compliance with applicable SOPs in sterile areas
  • Draft standard operating procedures (SOPs), particularly regarding the state of the art for aseptic processes (Good Aseptic Practice, GAP), and train the relevant staff
  • Prepare for and participate in internal and external audits (with authorities and customers)

Requirements

  • Degree in natural sciences (e.g., Biology, Biotechnology or Pharmacy) or equivalent qualification
  • Several years of experience in the production of sterile medicinal products
  • Several years' experience and extensive expertise in various sterile manufacturing and filling technologies, e.g., RABS / isolator technology
  • Extensive knowledge of applicable national and international regulatory standards and guidelines such as AMG, AMWHV, ICH, 21 CFR, EU GMP including annexes

Benefits

  • Permanent employment
  • Company collective agreement with a 37.5-hour workweek, 30 days annual leave and up to 10 days compensatory time off
  • Capital-forming benefits (employer contributions to savings schemes)
  • Good working atmosphere and cross-departmental teamwork
  • Exciting and challenging tasks
  • Trust and responsibility from day one
  • Excellent canteen with affordable prices
  • Free beverages
  • Company bicycle (JobRad) after one year of employment
  • Option to participate in the company pension scheme subject to good performance and willingness to undertake further training
  • Opportunities for professional development

Job title

Sterility Assurance Expert

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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