QUALIFICATIONS & REQUIRED SKILLS • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science • Knowledge of pharmaceutical GxP regulations and Quality system • · Strong understanding of GDP principles (EU GDP Guidelines). • · Experience in pharmaceutical quality systems or supply chain compliance. • · Experience working in dynamic, transformational environments. • · Ability to coordinate external service providers and internal stakeholders. • · Strong documentation, organizational, and communication skills. • • Experience in transformation, working in a dynamic environment. • Collaborative and team-oriented • Very good communication skills, and a customer-oriented approach. • Flexibility and ability to manage competing priorities. • Sense of urgency, high autonomy & stress resistance, agile personality • Proven hands-on attitude, be flexible and adaptable, open minded. • Open minded, positive, and energetic person • Good Microsoft applications knowledge and computer skills • Advanced knowledge of English 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.