Quality Assurance Specialist
Vor 7 Tagen
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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