Quality Assurance Architect (5219)
Quality Assurance Architect (GMP) – 5219 URA
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 currently supporting them and looking for a Quality Assurance Architect (GMP) to assist the Regulatory Compliance team. This role is a contract opportunity, which provides flexibility to work hybrid in model until the end of this year with high chances of extension to be based in Bern area.
· Authority and customer inspections at the site
· Preparation of GMP documents for regulatory submissions
· Responses to questions from regulators
· Coordination, performance, and follow-up of paper based GMP inspections.
· Preparation of GMP-certificate renewal and tender relevant documentation based on request by affiliates.
· Change Management: Ensuring timely implementation of Regulatory Compliance related actions.
· Supporting answers to Regulatory Compliance related questions from internal or external
· Perform Ad-Hoc duties in specialized field
· Participation in predetermined trainings
· Compliant performance of activities after appropriate training
Qualifications and Experience:
· Relevant working/residency permit or Swiss/EU-Citizenship required.
· University degree or university of applied sciences degree in natural sciences (e.g., Biology, Chemistry or Pharmacy)
· Experience in Quality or manufacturing in a pharmaceutical GMP environment
· Experienced in reading regulations.
· Demonstrated German and English skills (written and spoken)
· Demonstrated communication skills
· Demonstrated interest for technical processes
· Experience with management of Audits is required.