Quality Assurance Architect (6169)
The Life Science Career Network
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About the Client
Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.
We are seeking a highly skilled Quality Assurance Architect for a 7-month contract position at our client's headquarters in Bern. The role involves supporting the creation and implementation of an aseptic operator training program for a pharmaceutical manufacturing site in Bern. The role focuses on ensuring compliance with global procedures, regulatory requirements, and aseptic processing standards.
Key Responsibilities:
- Develop and update procedures and risk assessments related to aseptic processes.
- Ensure adherence to global quality standards and procedures.
- Create and maintain SOPs in key areas such as Microbiology, Hygiene, Aseptic Behavior, Transitional Spaces, and Gowning Procedures.
- Provide training to operators on aseptic processes, including microbiology, hygiene, and gowning.
- Support Annex 1 gap mitigation and remediation efforts in collaboration with the manufacturing department, including the creation of work instructions, risk assessments, and process designs.
Requirements:
- Languages: Proficiency in both German and English at a business level.
- Education: Degree in Life Sciences or a related field.
- Experience:
- Strong technical knowledge in sterility assurance for aseptic cleanroom facilities, equipment, personnel, and processes.
- Proven experience in the pharmaceutical manufacturing industry, particularly in aseptic processing.
- Familiarity with quality assurance and regulatory compliance, including EU GMP Annex 1.
Would you like to learn more about CTC and the opportunity outlined? Please get in contact with us: you may either use the 'apply now' button or write an email to vanessa.gilardoni@ctcresourcing.com.