The Sterility Assurance Expert Filling and Lyophilisation will serve as a subject matter expert and will be responsible for Sterility Assurance of sterile products manufactured in Filling & Lyophilisation production area.
The subject matter expert will provide leadership in training, development and empowerment of individuals in the area of responsibility to achieve business objectives related to quality with focus on Sterility Assurance.
In addition, this role includes managing relationships with local and global Quality Assurance Sterility Assurance functions and respective network.
Main areas of responsibility are:
- Planning, coordination and supervision of aseptic process simulations (APS)
- Routinely supervision of shop floor to review, train and develop operators related to hygiene behaviours and aseptic techniques
- Assess, revise, review, approve and be owner of local standard operations procedures (LSOP) with potential impact on Sterility Assurance
- Single point of contact for end-to-end accountable senior manager for Sterility Assurance related topics
- Contributes as a member of expertise network to the harmonization and continuous improvement of sterility assurance knowledge and practices on site
- Review and approval of quarterly environmental monitoring trending reports
- Owner of monitoring trending meeting to ensure excellent environmental and personal monitoring performance
- Facilitate and lead improvement initiatives related to but not limited to cleaning and disinfection, sterile wrapping of equipment, environmental monitoring programme and aseptic process simulations
- Subject matter expert for Sterility Assurance when production area is under inspection or audit
- Prompt escalation of sterility assurance issues and concerns in the production area
- Min. of Bachelor’s degree is required, a focused degree on in a Science-related discipline like Microbiology is preferred. An advanced degree like a Master’s or PhD is preferred
- Must have an understanding of vaccines/biologic products and associated technologies, sterility assurance and associated techniques
- A min. of 5 years’ experience in a cGMP controlled/pharmaceutical industry
- 3-5 years’ experience/knowledge of: cGMPs and regulatory requirements, contamination control, disinfection techniques, sterility assurance, aseptic processing
- Maintain knowledge of regulatory environment and requirements with regard to sterility assurance and aseptic processing
- Fluent in German required as well as good spoken and written English is preferred
- Excellent analytical, prioritization, communication and leadership skills required
as described above
GlaxoSmithKline is a world-leading, research-oriented healthcare company committed to developing innovative pharmaceuticals.
We are also the largest producer of vaccines in Germany.
Our goal is to improve people’s quality of life by enabling them to live longer, healthier, and more actively.
This challenge is in the hands of our employees. Everything depends on their commitment.
As a strategic location for GSK Vaccines, an international market leader in vaccine research & production, our business can look back over more than 110 years of tradition. In the attractive university town between Kassel and Frankfurt, we are working on keeping people healthy by developing vaccines and thus following in the footsteps of our company’s founder and the first Nobel Laureate in medicine, Emil von Behring.
You may apply for this position online by selecting the Apply now button.
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