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.