Ra & Qa Associate (M/F) - Lisboa

Kelly Science and Clinical is currently recruiting a QA / RA Associate, to work in the Lisbon area, with a Pharmaceutical and Medical Devices Consultancy company.Responsibilities as a QA / RA Associate include, but are not limited to:Collaborates with Regional and Global teams to support local planning and execution for Market Access procedures;Participates in Product/Project team work, delivering as per agreed timelines and needs under the scope of the Quality Assurance activity;Ensures regulatory submissions are made on time and meet corporate and local regulatory requirements;Monitors the external regulatory environment to help inform/advise in the regulatory decision making;Ensures/supports regulatory product compliance (e.g. agency commitments, …);Acts as the point of contact with the client's vendors (CROs) or, when applicable, directly with regulatory agencies in fulfilling local obligations;Writes technical and Quality performance indicators reports;Prepares and reviews quality related documentation;Participates in investigations, close deviations and propose CAPAs; Proposes, participates and assesses changes to established procedures or processes; Prepares and approves Quality Risk Assessments. The ideal candidate will have: Master's degree (pharmaceutical area);Degree and in-depth Regulatory and QA experience related to the country(ies).In-depth knowledge of country(ies) legislation and regulations relating to medicinal products and medical devices. If you are keen to apply for this role, or want to know more about it, please submit your CV through our portal. A Kelly Services atua na qualidade de Agência de Emprego, em relação à presente oferta. Informamos que se optar por se candidatar, as suas informações serão tratadas de acordo com a . _______ Kelly Services acts as an Employment Agency in relation to this offer. Please be advised that if you choose to apply, your information will be treated in accordance with the .