QualitySpecialist,Deviations&CAPAs

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. The Quality Specialist is responsible for ensuring that Deviations (Devs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and company requirements. * Lead the administration, tracking and management of Devs and CAPAs * Support Subject Matter Experts to conduct root cause analysis or Devs and CAPAs * Lead Devs and CAPAs through the workflow * Provide support to operations and act as subject matter expert on process of managing Devs and CAPAs * May participate in audits and inspections to act as a Dev and CAPA subject matter expert * May support team management, Dev and CAPA team for periodic trending of deviations data across the company * Preparing metrics on procedures and trainings for internal Quality and Compliance reporting ## Qualifications Education: * University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master degree in a scientific di