Quality Assurance Specialist

vor 2 Monaten


Bulle FR, Freiburg, Schweiz UCB Vollzeit

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our HSE & Quality Culture and Compliance department in Bulle, Switzerland.

Key Responsibilities

  • Actively participate in maintaining operational activities within the organization in compliance with GMP and UCB Quality standards.
  • Manage the qualification of GMP purchased materials and associated vendors, service subcontractors (risk assessments, change controls, documentation, etc.).
  • Manage and realize vendors' audits (questionnaires and on-site) planned for the year.
  • Responsible for vendors' quality agreement update and creation; and ensure their successful and timely implementation.
  • Responsible for the annual review of vendors.
  • Responsible for the vendor's change notification process (analysis of the document, creation of report, and responsible for change control if any).
  • Responsible for raw materials implementation & certification (testing & sampling) regarding quality aspects.
  • Active participation in updating and maintaining vendor documentation in the electronic documentation system (documentation with expiry, documentation with periodic review, qualification documentation).
  • Active participation in SAP configuration for vendors and purchased codes.
  • Coordination of relationships with vendors to ensure effective following of deviations, change controls, investigations, incidents, complaints, CAPAs, etc.

Requirements

  • Master's degree in Life Sciences.
  • Extensive track record of 10 years in comparable positions within the pharmaceutical industry.
  • Knowledge of SAP, LIMS (Laboratory Information Management System).
  • Analytical knowledge.
  • Demonstrated understanding of GMP environment.
  • Very good communication, negotiation, convincing and presentations skills.
  • Well-developed sense of discretion.
  • Demonstrated ability to write-up scientific/technical documents.
  • Ability to handle challenging situations, make decisions and work independently.
  • Ability to coordinate multifaceted projects and to meet/respect critical deadlines.
  • Sense of organization and priorities.
  • Very good computer skills, including but not limited to, Microsoft Word - Microsoft Excel – Outlook.
  • Languages: French and English (spoken and written).

Are you ready to make your mark for patients?



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