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.
