Quality Management Officer, Document Management
Posted: 4 days ago
Job Description
Company DescriptionErgomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and AsiaOur company allows for employee visibility (you have a voice!) creative contribution and realistic career development.We have nourished a true international culture here at Ergomed.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.Come and join us in this exciting journey to make a positive impact in patient’s lives.Job DescriptionThe Quality Management Officer for the Document Management team is responsible for ensuring that PrimeVigilance’s controlled procedures are managed in compliance with global regulations, legislation and PrimeVigilance requirements.Role And ResponsibilitiesSupporting the administration, tracking and management of PrimeVigilance Controlled ProceduresManaging and maintaining the PrimeVigilance electronic Quality Management System (eQMS)Reviewing and approving Access Requests to PrimeVigilance’s controlled systemsSupporting audits and inspections by providing reports and procedures from the PrimeVigilance eQMSProviding controlled copies of PrimeVigilance procedures to clients as neededSupporting PrimeVigilance functional teams in recording and tracking planned deviations and resulting CAPA plans against PrimeVigilance Controlled Procedures in eQMS as neededProviding training and mentoring to new starts as neededAssist the Senior Quality Manager with business related projects as neededMay act as a Trainer for QMS-related training activities provided by the Quality Management departmentQualificationsEducated to degree standard or appropriate equivalent work experienceRequired: Relevant experience in a Quality and/or Compliance-related roleDesirable: Prior experience in Pharmacovigilance, Medical Information, or Medical DevicesAdditional InformationWe 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 OfferTraining and career development opportunities internallyStrong emphasis on personal and professional growthFriendly, supportive working environmentOpportunity to work with colleagues based all over the world, with English as the company languageOur OfferCompetitive salaryDynamic team of colleagues in a fast-growing company – possibility for your quick career growthMulticultural environment, English as a company languageStrong emphasis on personal and professional growth
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