Quality Assurance Specialist
1 miesiąc temu
About Animal Health at Elanco
Foster a diverse and inclusive work environment
Elanco, a global leader in animal health, is driven by its vision of 'Food and Companionship Enriching Life.' The company's approach to sustainability, the Elanco Healthy Purpose, aims to advance the health of animals, people, the planet, and the enterprise. This approach is built on a foundation of diversity and inclusion, fostering a work environment where individuals can thrive.
Quality Assurance Role
The Elanco Solution Center (ESC) Quality Associate plays a critical role in managing operational activities related to the implementation, maintenance, and operations of the Quality Management System for the Elanco Solution Center. This includes providing independent quality oversight on ESC GxP activities and decisions.
Key Responsibilities
- Collaborate with the ESC Quality Manager and other ESC Quality Associates to ensure the Quality Management System is in place and activities managed by ESC comply with local regulations, GxP requirements, and Elanco quality standards.
- Provide guidance and support to ESC departments to resolve identified quality issues.
- Responsible for the completion and accuracy of ESC operational quality tasks, including deviations management, change control management, quality document management, and maintenance of the Quality Plan and Quality Agreements.
- Involved in continuous improvement, risk mitigation, routine self-assessment, corrective and preventative actions (CAPA), and use of the Quality Plan.
- Support Audit preparations and observation completion.
- Raise notifications to Management as required.
- Participate in activities related to QA Affiliate organization, including document/process review optimization and harmonization, recall activities, inventory management, and quality metrics monitoring.
- Manage Local Quality Object Requests in SAP S4/HANA as Regional Quality Master Data Steward.
- Support Affiliate QA organization (QM Power User/Super User) and provide additional ad hoc trainings for QA S4/HANA users.
Requirements
- Bachelor's degree in pharmacy, science, engineering, or a related field, or relevant experience.
- Fluent in English (written and verbal).
- Experience working in a GxP environment.
- Good knowledge of SAP (S4 HANA) – Quality Module and Quality Master Data Management.
- Good knowledge of standard MS Office tools.
- Effective organizational and planning skills.
- Good self-organization and independence.
- Effective communication (written/verbal) skills.
- Effective interpersonal skills, experience with cross-functional international cooperation.
- Demonstrated analytical and investigational skills with due attention to detail.
Preferred Qualifications
- Knowledge of Quality processes, including Batch Management, Recall activities, Product Complaint management, and Customer License management.
- Knowledge of O2C and Supply chain processes (Order Management, Return Management, and Inventory management).
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