Quality Assurance Specialist

KEY RESPONSIBILITIES AND ACTIVITIES

• Support maintenance of the Dutch WDA license in collaboration with the external RP service provider.
• Ensure all documentation required for WDA compliance is complete, current, and accessible.
• Coordinate internal inputs required for initial and ongoing WDA obligations.
• Maintain an overview of licensed activities and scope under the WDA
• Act as the primary internal contact for the external RP/WDA service provider.
• Ensure timely exchange of information between Zentiva and the RP.
• Coordinate review and routing of GDP‑relevant documents requiring RP approval.
• Track actions, commitments, and deliverables from the external provider
• Ensure alignment of local NL processes with Zentiva’s global QMS.
• Support implementation and maintenance of GDP‑related SOPs.
• Coordinate document control activities related to the WDA scope.
• Ensure training records and GDP compliance documentation are main
• Manage end‑to‑end complaints and deviation processes, ensuring accurate recording in Quality Forward and timely communication with manufacturing sites or External Supply Operations (ESO).
• Coordinate intake and tracking of GDP‑relevant deviations and CAPAs.
• Ensure proper escalation to RP and corporate QA Comm Ops where required.
• Track closure of quality actions linked to distribution activities.
• Ensure change controls impacting WDA scope are properly assessed.
• Support preparation of documentation for GDP inspections
• Coordinate responses to audit questions in collaboration with RP and corporate QA.
• Maintain an inspection‑readiness folder/document repository.
• Support execution of internal audits where applicable.
• Coordinate information flow related to product distribution activities performed outside NL.
• Ensure traceability of product flow and availability of GDP‑compliant documentation.
• Support verification that outsourced logistics providers operate under GDP requirements.
• Support development and monitoring of KPIs for Commercial Quality and WDA compliance.
• Maintain oversight of WDA‑related KPIs and compliance status.
• Provide periodic updates to internal stakeholders (QA, Supply Chain, Regulatory, Finance).
• Highlight risks, gaps, or delays impacting compliance or licensing obligations.

Quality Assurance Specialist

OTHER RESPONSIBILITIES

QUALITY

• Ensure full adherence to GxP principles and internal Quality standards
• Maintain compliance with applicable regulatory requirements

HSE

• 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.

PHARMACOVIGILANCE

• 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.

COMPLIANCE

• The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

PHARMACOVIGILANCE

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