Senior Specialist, Quality Assurance Auditor

hace 1 hora

Buenos Aires, Argentina SAP A tiempo completo

Senior Specialist, Quality Assurance Auditor Organon Description The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks. Responsibilities Evaluate Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements. Schedule and conduct GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations. Prepare audit reports and manage follow-up activities with limited guidance. Conduct meetings with Senior Management to discuss audit observations and responses. Support the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan. Responsible to ensure audit tracking tools are up to date. Participate in regulatory inspections and external audits, when required. Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF). Maintain a high degree of knowledge of global industry expectations and GVP/GCP regulations. Train and mentor junior team members. Required Education, Experience and Skills Bachelor’s degree in a relevant field (Pharmacy, Life Sciences, etc.). Fluency in written and spoken English; additional language skills a plus. Minimum of five (5) years of experience in the pharmaceutical industry. Minimum of one (1) year of experience in GVP/GCP auditing with EU/FDA/global regulatory requirements. Strong knowledge of EMA, FDA and ICH guidelines. Attention to detail and ability to work independently. Collaboration and partnering: ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills. Communication Skills: strong verbal and effective writing skills. Project Management: ability to organize work efforts, prioritize tasks and utilize appropriate resources to deliver work products in accordance with timelines and regulations. Decision Making: ability to use knowledge, networks, and data to make rapid and appropriate decisions and escalate issues when necessary. Business Operations/Knowledge of Field: knowledge of regulations and regulatory trends and applying this knowledge to ensure compliance within R&D and related processes. #J-18808-Ljbffr

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