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As a quality contact for the Affiliate organization and Order to Cash Operations, the Quality Associate manages the day-to-day activities relating to the implementation, maintenance and operations of the Quality system for the Solutions Center.
The Quality Associate will support the Quality Manager to provide independent quality oversight GxP activities and decisions in collaboration with the Affiliate Quality organization to ensure specific Affiliate requirements are met.
The Quality Associate will work closely with business partners in both the Affiliate organization and Solucion Center to ensure Quality activities operate in an efficient manner.
- Work with the Quality Manager to ensure that the Quality Systems in place to support activities managed through SC comply with the applicable GxP, other applicable company quality standards and local regulations
- Support Quality Management activities within the ERP (SAP) system associated to Customers and Material Master (QM Power user & QM Data Steward activities)
- Support Quality Management activities including but not limited to Recall activities, Product Complaint management, Customer License management, Inventory management (expiration, returns, adjustments)
- Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan
- Support Audit preparations and observation completion
- Raise Notifications to Management, if and when required
- Responsible for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, quality document management and maintenance of the Quality Plan, Quality Agreements
- Monitor, trend, interpret & report on Quality metrics
- Help and give guidance on resolution of Quality issues
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies
- Perform any other duties or serve in such other capacity as may be determined by Company management
- Bachelor degree in pharmacy, science, engineering, or related field and / or relevant experience
- Previous experience working in a GxP environment
- Ability to work with others
- Attention to detail
- Effective communications (written/verbal) skills
- Experienced in both Microsoft Office and SAP
- Demonstrated analytical & investigational skills
- Effective organizational and planning skills
- Fluent in English (written & verbal)
- Inventory management and QM data knowledge highly regarded