Quality Assurance Specialist

Vor 7 Tagen


Lausanne, Waadt, Schweiz Axepta SA Vollzeit
Job Description

We are seeking a highly skilled Quality Assurance Supplier Engineer to join our team at Axepta SA. As a key member of our global team, you will be responsible for the management of all suppliers at our pharmaceutical manufacturing site in the canton of Vaud.

Key Responsibilities:

  • Coordinate daily quality assurance activities related to supplier management, including supplier qualification, performance monitoring, audits, and change notifications.
  • Draft, review, and approve necessary documentation to maintain compliance with cGMP.
  • Oversee the supplier audit program, including evaluation, approval, and continuous monitoring.
  • Ensure timely execution of supplier audits as per the scheduled plan.
  • Conduct supplier audits when required.
  • Create and maintain documented procedures for managing suppliers.
  • Handle, review, and approve deviations, investigations, and CAPA plans.
  • Evaluate and authorize changes for implementation.
  • Manage and update the supplier and material list within the QMS system.
  • Support inspections by health authorities, such as Swissmedic and FDA, within your area of expertise.

Requirements:

  • Degree in sciences, such as pharmacy or biotechnology.
  • At least 5 years' experience in Quality Assurance roles within the pharmaceutical industry, including supplier management and supplier audits.
  • Strong knowledge of GMP.
  • Fluent in French and English.

About Us:

Axepta SA is a dynamic global company committed to excellence in pharmaceutical manufacturing. We offer a collaborative and challenging work environment that fosters growth and development.



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