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
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