Aseptic Process Assurance Expert
vor 10 Stunden
At Consultys, we are expanding our team of experts to support the growth of our business.
Job SummaryWe are seeking an Aseptic Process Assurance Expert to join our team. In this role, you will be responsible for ensuring the highest standards of quality and compliance in aseptic processing.
Main Responsibilities:- Create and implement effective aseptic operator training programs
- Develop and update procedures and risk assessments to ensure global standards are met
- Ensure adherence to cGMP regulations and industry best practices
- Design and create SOPs for aseptic processing areas, including microbiology, hygiene, and gowning procedures
- Train operators on aseptic processes and manufacturing practices
- Support Annex 1 gap mitigation and remediation efforts in collaboration with the manufacturing department
To be successful in this role, you will need:
- A minimum of 4 years' experience in the pharmaceutical manufacturing industry, specifically in aseptic processing
- Demonstrated expertise in sterility assurance, aseptic cleanroom facilities, and personnel design and management
- Experience with EU GMP Annex 1 and cGMP compliance
- Fluency in both English and German languages
Consultys offers a dynamic work environment and opportunities for professional growth and development.
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