Quality Specialist, Audit and Inspection Findings and CAPA

Job description

Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Job Description The Quality Specialist, Audit and Inspection Findings and CAPA ensures Ergomed groups Audit and Inspection Findings and CAPAs are managed in compliance with global regulations, legislation and internal requirements. Leadership and Compliance: Provide support and guidance to Ergomed colleagues and functional teams in developing, managing, and implementing Audit and Inspection Findings and CAPAs. Ensure GxP activities are conducted in compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO. May act as the Subject Matter Expert to Ergomed group staff over Audit and Inspection Findings and CAPAs and requirements related to GxP Quality Operations as required. Training and Development: Guide Audit and Inspection Findings and CAPA training activities across the Ergomed group, ensuring employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team. Quality Management System Oversight: Participate in efficiency projects to enhance the use and management of the Ergomed Group Quality Management System. Audit and inspection Support: Provide support to functional and Quality teams for audits and inspections by supplying reports or procedures from the Ergomed Group Quality Management System. Metrics and Reporting: Assist in the preparation and analysis of team related metrics, providing periodic reports to management. Take a role in preparing any required CAPA or Deviation records resulting from issues in the Audit and Inspection Findings and CAPAs. Team Leadership and Development Assist in mentoring and leading the Audit and Inspection Findings and CAPA team helping to develop team members and to build competence, confidence, and subject matter expertise. Foster a collaborative, high‑performing quality culture across global teams and regions. Provide coaching and professional development opportunities to enhance team capability and succession planning. Qualifications University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or suitable experience. LANGUAGE SKILLS: English - fluent (spoken, written) Additional Information Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.