Quality Assurance Specialist

Vor 7 Tagen


Bulle FR, Freiburg, Schweiz UCB Vollzeit

About the Role

At UCB, we are seeking a skilled Quality Assurance Specialist to join our HSE & Quality Culture and Compliance department. As a key member of our team, you will be responsible for maintaining operational activities within the organization in compliance with GMP and UCB Quality standards.

Key Responsibilities

  • Manage the quality vendor process and ensure its effective application.
  • Qualify GMP purchased materials and associated vendors, including risk assessments, change controls, and documentation.
  • Plan and execute vendors' audits, ensuring timely and successful implementation.
  • Update and create vendors' quality agreements and ensure their successful implementation.
  • Conduct annual reviews of vendors and manage vendor change notifications.
  • Implement and certify raw materials regarding quality aspects.
  • Maintain vendor documentation in the electronic documentation system.
  • Coordinate 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 and LIMS.
  • Analytical knowledge and understanding of GMP environment.
  • Excellent communication, negotiation, convincing, and presentation skills.
  • Well-developed sense of discretion and ability to write scientific/technical documents.
  • Ability to handle challenging situations, make decisions, and work independently.
  • Language proficiency in French and English.


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