The Quality Management System Associate is responsible for ensuring the Quality Systems meets the company's and legal requirements and is responsible for continuous Quality improvement activities related to activities & quality projects related to the QMS. The Quality Management System Associate acts as a backup for key quality processes.
Good Distribution Practices:
- Ensure quality incidents and deviations related to the Quality Management System and Feed activities are registered, escalated, investigated and effective Corrective and Preventive actions and Commitments are defined and implemented
- Ensure Change Controls are documented and followed-up appropriately
- Ensure the timely (re)qualification of company's customers in compliance to local & global procedures
- Ensure relabelling protocols are created per regulatory expectations
- Act as a back-up for GDP Release Activities, GDP Return Assessments, Temperature Excursion handling and Stock Status management in the WMS and at the LSP
Supply Chain & Logistics Quality System
- Ensure company's Quality Systems are implemented and maintained in accordance with local and global procedures and regulatory requirements
- Ensure global company's procedures are implemented in the local Quality Manual in accordance with local and global expectations and regulatory requirements
- Develop, maintain and revise local instructions and procedures related to the QMS and Feed activities in accordance with regulatory requirements
- Support non-QO departments in developing and maintaining local instructions and procedures in accordance with Quality Management System Requirements and Good Documentation Practices
- Act as Training System Representative and ensure the timely creation of training content and assignment of the training content in the Learning Management System
- Act as Document Management System Representative and ensure continuous maintenance of the Quality Manual and timely execution of periodic review activities on local instructions and procedures of the Quality Manual
- Ensure documents are archived per the local and global expectations and regulatory requirements
- Act as Quality point of contact for activities related to the QMS, Feed, Customer Qualification and the archive.
- Ensure appropriate follow up on incidents deviations and CAPA
- Act as responsible for all QMS related incidents; Deviations and CAPA, Change Controls, commitments
- Manage and deploy projects related to the QMS
- Track and prevent deviation and CAPA overdues in collaboration with Operational Stakeholders
- Conduct periodic trending analysis of Quality Management System performance
- Manages Feed activities including the management of Undesirable substances and HACCP plan management;
- Act as Risk Management Champion
- Participation in and execution of self-inspections of procedures and systems
Compliance
- Contributes to and is compliant with related activities such as SOP’s and Training.
- Support in maintaining compliance to Feed regulation and Certification requirements and expectations
Continuous improvement
- Proactively looks for opportunities for improvement.
- Drives agreed implementation of changes that enhance performance, productivity and cost. Seeks opportunities to improve existing systems, processes and performance.
- Implement and maintain state-of-the-art Good Practice guides on the management of incidents, deviations, CAPAs, Change Controls and Risk Analysis.
- Support company's employees in documenting and investigating incidents and deviations, raising and implementing Corrective and Preventive actions, issuing and implementing Change Controls and conducting Risk Analysis as per Good Practices.