Quality Assurance Specialist
vor 2 Monaten
About the Role
As a Quality Operations QA Specialist at UCB, you will play a critical role in ensuring compliance with national and international regulations, guidelines, and quality policies. Your responsibilities will include managing compliance activities and quality strategies related to product delivery, from start to finish.
Key Responsibilities
- Provide quality support for product delivery, including management of activities and processes related to deviations, OOS, CAPAs, Change Control, Complaints, equipment qualification, process validation, and GxP documentation.
- Establish and maintain relationships with internal and external customers to provide efficient follow-up of product-related issues.
- Enforce compliance with stakeholders related to relevant product flow, UCB standards, and GxP.
- Lead and participate in internal audits and inspections.
- Contribute to the development and approval of SOPs, methods, specifications, and master batch records.
- Perform batch record review and release/reject activities as needed.
Requirements
- Master's degree in Life Sciences or equivalent working experience.
- Minimum 3-5 years of experience in manufacturing, laboratory, quality assurance/control, or regulatory affairs.
- Ability to coordinate multifaceted projects and meet critical deadlines.
- Independent worker with excellent negotiation and convincing skills.
- Excellent oral and written communication skills in French and English.
Join UCB in creating value and making a mark for patients.
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