Senior Aseptic Process Specialist
Vor 3 Tagen
We are seeking a highly skilled Senior Aseptic Process Specialist to support the creation and implementation of aseptic operator training programs, ensuring adherence to global procedures and standards.
Key Responsibilities:
- Create and update procedures and risk assessments to ensure compliance with cGMP regulations
- Develop Standard Operating Procedures (SOPs) for aseptic processing areas, including microbiology, hygiene, and gowning procedures
- Train operators on aseptic processes and manufacturing in designated areas
- Collaborate with the manufacturing department to mitigate Annex 1 gaps and remediate any issues
About You:
- Minimum 4 years of experience in the pharmaceutical manufacturing industry, specifically in aseptic processing
- Demonstrated expertise in sterility assurance, process design, and life cycle management
- Strong understanding of EU GMP Annex 1 and regulatory compliance
- Fluent in English and German
What We Offer:
- An estimated salary range of $90,000 - $120,000 per annum, depending on experience and qualifications
- A dynamic and supportive work environment at Consultys
- Ongoing professional development opportunities
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