W skrócie
- Zadania: Prowadzenie i wsparcie działań związanych z zarządzaniem CAPA dla istotnych problemów jakościowych.
- Firma: IQVIA, wiodący dostawca usług badań klinicznych i inteligencji zdrowotnej.
- Benefity: Konkurencyjne wynagrodzenie, możliwości rozwoju zawodowego i elastyczne godziny pracy.
- Pozostałe informacje: Dynamiczne środowisko z możliwościami rozwoju kariery w branży zdrowotnej.
- Dlaczego ta praca: Zyskaj doświadczenie w zarządzaniu jakością i wpływaj na poprawę wyników pacjentów.
- Kwalifikacje: Doświadczenie w zarządzaniu CAPA oraz umiejętności analizy przyczyn źródłowych.
Przewidywane wynagrodzenie mieści się w przedziale 72000 - 88000 zł za rok.
Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives. Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.
Essential Functions
- Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed.
- Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines.
- Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements.
- Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines.
- Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes.
- Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff.
- Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence.
- Develop and/or improve governing procedures, templates and work instructions, in order to streamline processes and drive compliance.
- Advise Quality Assurance management on system audit needs.
- Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times.
Qualifications
- Bachelor's Degree
- Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials is a must.
- Prior experience in audit and inspection management/support.
- Root cause analysis and quality investigations.
- Able to independently manage complex quality issues with minimal supervision.
- Experience reviewing and driving CAPAs to closure.
- 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials.
- Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines.
- Possess strong leadership and organizational skills for prioritizing workload and responsibilities.
- Excellent problem solving and root cause analysis skills.
- Excellent training and mentoring capabilities.
- Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment.
- Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.
- Proficient in Microsoft Office applications (Word, Excel).
Sr. Quality Auditor, CAPA Centre of Excellence in Warsaw – pracodawca: IQVIA
IQVIA to wiodąca globalna firma zajmująca się badaniami klinicznymi oraz analizą danych w sektorze ochrony zdrowia, oferująca wyjątkowe możliwości rozwoju zawodowego w dynamicznym środowisku. Pracując w zespole HE/HTA/V&A, będziesz mieć szansę na współpracę z czołowymi klientami w branży farmaceutycznej, a także na rozwijanie swoich umiejętności w zakresie innowacyjnych strategii dostępu do rynku. Nasza kultura pracy opiera się na współpracy, różnorodności i ciągłym doskonaleniu, co sprawia, że jesteśmy atrakcyjnym pracodawcą dla osób poszukujących znaczącej i satysfakcjonującej kariery.
