Quality Associate
hace 4 días
Education : EQUIVALENTEXPERIENCE
**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**
**Position Description**:
The ESC Quality Associate supports the ESC Quality Manager in managing operational activities relating to the implementation, maintenance and operations of the Quality Management System for the Elanco Solutions Center and providing an independent quality oversight on ESC GxP activities and decisions
The ESC Quality Associate acts as a quality contact for ESC teams and as ESC quality contact for the Elanco Affiliates. Works closely with business partners in both the ESC, Affiliates and Affiliate QA organization to ensure quality activities are managed in an efficient manner and specific Affiliate requirements are met.
The ESC Quality Associate acts as Regional Quality Master Data Steward assuring that Affiliate Requests for Local Quality Objects are correctly managed in S4 HANA.
**Responsibilities**:
In the role of ESC QA Associate:
- Cooperate with other ESC Quality Associates and ESC Quality Manager to ensure that the Quality Management System is in place to assure that activities managed by ESC comply with the applicable local regulations, GxP requirements and other applicable Elanco quality standards.
- Provides guidance and help to ESC departments on resolution of identified quality issues
- Responsible for the completion & accuracy of ESC operational quality tasks, including but not limited to 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
- Participates in activities related to QA Affiliate organization including but not limited to document / process review optimization and harmonization, recall activities, inventory management (stock reconciliation etc.)
- Monitor, trend, interpret & report on Quality metrics
In the role of Regional Quality Master Data Steward:
- Responsible for managing Local Quality Object Requests in SAP S4/HANA
- Supports Affiliate QA organization (QM Power User/Super User), providing additional ad hoc trainings for QA S4/HANA users
Others:
- Comply with all company global and local policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment and HSE (Health, Safety and Environment) policies.
- Perform any other duties or serve in such other capacity as may be determined by Company management.
**Requirements**:
- Bachelor's degree in pharmacy, science, engineering, or related field and / or relevant experience
- Fluent in English (written & verbal)
- Experience with 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 communications (written/verbal) skills
- Effective interpersonal skills, experience with cross-functional international cooperation
- Demonstrated analytical & investigational skills with due attention to detail
- Knowledge of Quality processes (incl. but not limited to Batch Management, Recall activities, Product Complaint management, Customer License management and knowledge of O2C and Supply chain processes (i.e. Order Management, Return Management, and Inventory management - expiration, stock adjustment etc.) would be advantage.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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