Analyst

1 semana atrás


Lisboa, Portugal Randstad Ii - Prestação De Serviços, Limitada Tempo inteiro

.In partnership with our client, a prestigious reference company in the pharmaceutical sector, we are recruiting an Analyst. Responsabilidades Chave Implements and manages the required guidelines and cGMPs for the company, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company's strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several company sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents the company through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for company and customer products; and within professionalassociations, industry/trade groups.Promote high-quality work within the team and a mindset of continuous improvement.Advise Team Members when unconformities with Quality or Regulatory Systems and Tools have been identified and promote corrective actions.Propose new procedures and/or policies according to the requirements applicable to the company business and strategy and review existing procedures.Prepare Quality and/or Regulatory Systems and Tools related documentation and training.Participate in Audits/inspections (Internal and of Health Authorities).Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI's, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.G., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support, etc.Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.Propose improvements to the area as appropriate and solve problems.Lead initiatives within group or department, ensuring plan definition and timely execution.Make quality and timely decisions within the Quality and/or Regulatory Systems' tasks under her/his responsibility.Gather relevant data to inform the decision makers regarding complex issues.Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice



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