Quality Assurance Specialist
vor 2 Monaten
About the Role
As a Quality Assurance Specialist at UCB, you will play a critical role in ensuring the quality and compliance of our products. Your responsibilities will include:
- Providing quality support related to product delivery from start to finish, including management of activities and processes related to deviations, OOS, CAPAs, Change Control, Complaints, and GxP documentation.
- Establishing and maintaining relationships with internal and external stakeholders to provide efficient follow-up of product-related issues.
- Enforcing compliance of stakeholders related to relevant product flow, UCB standards, and GxP.
- Ensuring that equipment and processes are qualified and validated according to current guidelines.
- Leading and participating in internal audits and inspections.
- Contributing to the development and approval of SOPs, methods, specifications, and master batch records.
- Performing batch record reviews and release/reject activities as needed.
Requirements
- 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.
- Ability to coordinate multifaceted projects and meet critical deadlines.
- Independent worker under tight and shifting priorities.
- 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.
- Demonstrated ability to write scientific/technical documents.
- Excellent oral and written communications skills in French and English.
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