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.