Career Opportunities: Senior Quality Assurance Manager- Research

2 meses atrás


Porto, Portugal Bial Tempo inteiro

Career Opportunities: Senior Quality Assurance Manager- Research (3723) Requisition ID 3723 - Posted 13/07/2023 - Portugal - Porto Responsible for managing GCP and GVP Quality Management Systems of Research and Development activities in accordance with applicable legal, regulatory and other Quality standard requirements, following the defined guidelines and goals set by the Company. MAIN ATTRIBUTIONS AND RESPONSIBILITIES• Manage Annual Audit Programs, since planning until closure and supervise subcontracted auditors of those fields;• Manage deviations and change controls in QMS;• Manage periodic reports, ensuring they are performed timely;• Host Regulatory Inspections;• Conduct audits according to the competences defined in the approved Qualification Matrix;• Monitor Annual Budget;• Prepare and / or verify SOPs, along with other related documentation;• Verify the conformity of Quality Management Systems with applicable requirements;• Comply with the Policies, Standards and Procedures in place;• Collaborate in all department activities, as needed.PREFERENTIAL REQUIREMENTS AND FACTORS• Degree in Health Sciences: Pharmaceutical Sciences, Pharmaceutical Medicine or similar;• Training in Clinical and/ or Pharmacovigilance audits;• Previous work experience in GCP and/or GVP;• Knowledge in Quality and Document Management Systems.• Strong computer and digital skills;• Proficiençy in English.#J-18808-Ljbffr



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