Recruiter in Herent
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
- 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
- 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.
- Scientific background with min 3 years experience in Quality management in a pharmaceutical company.
- Knowledge of current Good Distribution Practices (GDP)
- Good organizational and computer skills
- Good written and verbal communication skills: English, Dutch and/or French
Consultancy project - pregnancy replacement for 6 months. (open for freelancers)