Position title: Quality Systems Management Expert
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
- Technical University Degree (health, pharma, technical, chemical areas are advantage)
- 6 to 10 years industry experience specifically Quality Systems, Complaint Management, Events/Deviations, CAPA Management, Change Controls, eQMS administration or related GxP disciplines.
- Organizational and analytical skills associated with proficiency in quality management and continuous improvement.
- Critical thinking ability and risk management and risk- based knowledge and approach.
- Ability in partnering with a proactive and solution- oriented approach.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a quality function
- Ability to work effectively in a matrix cross-functional environment.
- Strong capacity for working independently with minimal supervision.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)
- Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.
Job Purpose:
The Quality Systems Management Expert is responsible for supporting quality system processes within the Quality Shared Services Centre (QSSC), including complaint management support, event tracking, CAPA and change control follow-up, document translation coordination, Quality Forward (QF) administration and compliance tracking activities.
The role provides operational support to affiliates, sites and quality functions by ensuring timely creation, maintenance, tracking and follow-up of quality records, actions and documentation. The role contributes to compliance, data integrity, inspection readiness and continuous improvement across quality management system processes.
MAIN ACCOUNTABILITIES AND DUTIES
- Complaint Management Support
- Receive, review, translate and process product quality complaints.
- Create and maintain complaint records in Quality Forward (QF).
- Forward complaints to the responsible entity for investigation and follow up on timely closure.
- Maintain complaint trackers and status reports.
- Event, CAPA & Change Control Coordination
- Create and maintain event, CAPA and change control records in QF.
- Monitor progress, action items and closure timelines.
- Follow up on overdue actions and escalate delays where required.
- Maintain trackers, compliance dashboards and performance reports.
- Investigation Review Support
- Perform first-level review of investigation reports for completeness, consistency and supporting documentation.
- Consolidate and communicate review comments to responsible stakeholders.
- Track resolution of review comments and follow-up actions
- Quality Forward Administration
- Maintain quality system records and ensure data integrity within QF.
- Support workflow administration, document management and routine QF activities.
- Generate reports, metrics and dashboards.
- Compliance Monitoring & Reporting
- Monitor complaints, events, CAPAs and change controls for compliance with established timelines.
- Support KPI generation, trend monitoring and management reporting.
- Escalate recurring issues, overdue records and compliance risks.
- Support identification of improvement opportunities based on complaint, deviation, CAPA and change control trend analysis.
- Inspection Readiness & Continuous Improvement
- Maintain inspection-ready records and documentation.
- Support audits and inspections through provision of documentation and tracking information.
- Participate in process harmonization, continuous improvement and digitalization initiatives.
OTHER RESPONSIBILITIES
QUALITY
- Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.
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*
*) country specific
- The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.
SUSTAINABILITY
- Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet
COMMUNICATIONS & WORKING RELATIONSHIPS
Internal
- Communicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and shared services
External
- Communication with External suppliers.
