Quality Assurance Specialist
4 weken geleden
AbbVie is seeking a highly skilled Quality Assurance Specialist to join our team in Zwolle, Netherlands. As a key member of our quality assurance team, you will play a critical role in ensuring the quality of our distribution and logistics operations, as well as ensuring compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) regulations.
Key Responsibilities- Execute operational processes related to quality systems, ensuring compliance with GxP guidelines and AbbVie policies.
- Advise staff on quality systems, providing guidance on executing activities in compliance with regulations.
- Evaluate quality system performance through performance management and initiate improvement programs.
- Support training on good distribution and manufacturing practices, based on AbbVie's quality assurance principles.
- Participate in QA projects and support Continuous Improvement activities.
- Execute change management, impacting documentation, training, and quality systems.
- Provide QA support for repackaging, relabeling, and secondary packaging activities.
- Contribute to the continuous improvement and compliance of the local quality system.
- Support external quality inspections and audits.
- Implement activities to support business expansion and network optimizations.
- Execute against ER's, Non-Conformities, Deviations, Complaints framework.
- Identify opportunities for KPI and PI improvements.
- Provide input to the Management Review process.
- Bachelor's degree with relevant specialization, preferably in pharmaceutics, biology, or life science.
- 2+ years of experience with implementing and maintaining quality systems in a pharmaceutical environment.
- Knowledge of GDP and/or GMP is an advantage.
- Excellent writing and communication skills in English.
- Excellent skills in Microsoft Office.
- Experience with working in SAP or similar ERP system and TrackWise is preferred.
- Able to take leadership and own challenges.
- Persistent and resilient when confronted with obstacles.
AbbVie is an equal opportunity employer, committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We offer a hybrid working model, with the possibility of working from home and in our office in Zwolle. If you are passionate about quality assurance and compliance, and want to join a dynamic team, please apply for this exciting opportunity.
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