Quality Assurance Specialist

**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.