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 valuable 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