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.