Sales Team Leader leading sales agents at Miway, focusing on performance and compliance in the commercial insurance sector.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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