Quality Assurance Specialist
vor 4 Wochen
About the Role
As a Quality Operations QA Specialist at UCB, you will be responsible for ensuring compliance with national and international regulations, guidelines, and quality policies related to product delivery. Your key responsibilities will include:
- Providing quality support for product delivery from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, change control, complaints, equipment qualification, process validation, and GxP documentation.
- Establishing and maintaining relationships with internal and external customers to provide efficient follow-up of product-related issues.
- Ensuring compliance of stakeholders related to relevant product flow, UCB standards, and GxP.
- Leading and participating in internal audits and inspections.
- Contributing to the development and approval of SOPs, methods, specifications, and master batch records.
Requirements
To be successful in this role, you will need:
- A Master's degree in Life Sciences or equivalent working experience.
- A minimum of 3 to 5 years of experience in manufacturing, laboratory, quality assurance/control, or regulatory affairs.
- Excellent negotiation and convincing skills.
- Well-developed sense of discretion.
- Demonstrated oral and written communication capabilities with varying, culturally diverse groups and/or individuals and/or functions.
- Demonstrated understanding of the GxP environment and technical competence in core areas of pharmaceutical product manufacturing.
- Excellent oral and written communications skills in French and English.
Join UCB in creating value and making a mark for patients
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