Sterility Assurance Expert ensuring sterile processes within pharmaceutical production at Wasserburger Arzneimittelwerk GmbH. Focused on aseptic processes and compliance with regulations and standards.
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, autoclave/steam sterilization processes, VHP decontamination, depyrogenation, and CIP/SIP
Provide appropriate training and instruction to personnel
Perform quality oversight for the execution of media fills and support their evaluation, including creation 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
Prepare standard operating procedures (SOPs), particularly regarding state-of-the-art 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 a natural science (e.g., Biology, Biotechnology, Pharmacy) or equivalent qualification
Several years of experience in sterile pharmaceutical manufacturing
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 the German Medicines Act (AMG), AMWHV, ICH, 21 CFR, and EU GMP including annexes
Benefits
Permanent employment
Company collective agreement with a 37.5-hour work week, 30 days of annual leave, and up to 10 days compensatory time off
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