Quality Assurance Specialist

1 dzień temu

Warszawa, Mazovia, Polska Elanco Pełny etat

About Elanco

At Elanco, we're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

Job Summary

The Elanco Solution Center (ESC) Quality Associate plays a crucial role in managing operational activities related to the implementation, maintenance, and operations of the Quality Management System for the Elanco Solution Center.

This role involves providing independent quality oversight on ESC GxP activities and decisions, acting as a quality contact for ESC teams, and working closely with business partners in both the ESC, Affiliates, and Affiliate QA organization to ensure quality activities are managed efficiently.

Key Responsibilities

  • Cooperate with other ESC Quality Associates and ESC Quality Manager to ensure the Quality Management System is in place to assure that activities managed by ESC comply with applicable local regulations, GxP requirements, and other applicable Elanco quality standards.
  • Provide guidance and help to ESC departments on resolution of 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, Quality Agreements.
  • Involved in continuous improvement and 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, if and when required.
  • Participate in activities related to QA Affiliate organization, including document/process review optimization and harmonization, recall activities, inventory management (stock reconciliation, etc.).
  • Monitor, trend, interpret, and report on quality metrics.
  • Manage Local Quality Object Requests in SAP S4/HANA.
  • Support Affiliate QA organization (QM Power User/Super User), providing additional ad-hoc trainings for QA S4/HANA users.

Requirements

Education

Bachelor's degree in pharmacy, science, engineering, or related field, and/or relevant experience.

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.

Additional Preferences

  • Knowledge of quality processes (including but not limited to Batch Management, Recall activities, Product Complaint management, Customer License management).
  • Knowledge of O2C and Supply chain processes (Order Management, Return Management, and Inventory management – expiration, stock adjustment, etc.).

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