Quality Systems Management Expert

• Complaint Management Support Receive, review, translate and process product quality complaints. Create and maintain complaint records in Quality Forward (QF). Forward complaints to the responsible entity for investigation and follow up on timely closure. Maintain complaint trackers and status reports.
• Receive, review, translate and process product quality complaints.
• Create and maintain complaint records in Quality Forward (QF).
• Forward complaints to the responsible entity for investigation and follow up on timely closure.
• Maintain complaint trackers and status reports.
• Event, CAPA & Change Control Coordination Create and maintain event, CAPA and change control records in QF. Monitor progress, action items and closure timelines. Follow up on overdue actions and escalate delays where required. Maintain trackers, compliance dashboards and performance reports.
• Create and maintain event, CAPA and change control records in QF.
• Monitor progress, action items and closure timelines.
• Follow up on overdue actions and escalate delays where required.
• Maintain trackers, compliance dashboards and performance reports.
• Investigation Review Support Perform first-level review of investigation reports for completeness, consistency and supporting documentation. Consolidate and communicate review comments to responsible stakeholders. Track resolution of review comments and follow-up actions
• Perform first-level review of investigation reports for completeness, consistency and supporting documentation.
• Consolidate and communicate review comments to responsible stakeholders.
• Track resolution of review comments and follow-up actions
• Quality Forward Administration Maintain quality system records and ensure data integrity within QF. Support workflow administration, document management and routine QF activities. Generate reports, metrics and dashboards.
• Maintain quality system records and ensure data integrity within QF.
• Support workflow administration, document management and routine QF activities.
• Generate reports, metrics and dashboards.
• Compliance Monitoring & Reporting Monitor complaints, events, CAPAs and change controls for compliance with established timelines. Support KPI generation, trend monitoring and management reporting. Escalate recurring issues, overdue records and compliance risks. Support identification of improvement opportunities based on complaint, deviation, CAPA and change control trend analysis.
• Monitor complaints, events, CAPAs and change controls for compliance with established timelines.
• Support KPI generation, trend monitoring and management reporting.
• Escalate recurring issues, overdue records and compliance risks.
• Support identification of improvement opportunities based on complaint, deviation, CAPA and change control trend analysis.
• Inspection Readiness & Continuous Improvement Maintain inspection-ready records and documentation. Support audits and inspections through provision of documentation and tracking information. Participate in process harmonization, continuous improvement and digitalization initiatives.
• Maintain inspection-ready records and documentation.
• Support audits and inspections through provision of documentation and tracking information.
• Participate in process harmonization, continuous improvement and digitalization initiatives.

• Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

*) country specific

• The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

• Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet

• Communicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and shared services

• Communication with External suppliers.