Agati Systems

Role & responsibilities To support the QA department (Maintenance of QMS documents) & CSV Computer System Validation & Training Records. Manage the auditing process and keep detailed records. To collaborate with the QA team to ensure that the different departments meet the quality standards and collaborate in the audits contracted by suppliers and internal auditors. All this under the established standards in terms of SOPs, Good Clinical Practice, and the needs of the client. Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance. Manage in the definition of internal tools and remote audit indicators. Participate in the review and follow-up of corrective action plans for internal compliance, Data Protection, audits, and regulatory inspections. Help the QA team in the proposals for revision and communication of the corrective/preventive measures of Quality Assurance. Maintain the databases and electronic file systems for Quality Assurance. Create, update, and collect SOPs, templates, and forms/documents. Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance. Support the QA manager with the coordination of audits (external by clients or inspections and internal audits or internal Vendor Qualifications management). Assist in audit preparing activities such as QA Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments. Assist the QA Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc. Support QA, IT and DM in the validation activities (document review, filing, uploading in the system and approval). Any other reasonable task that derives from the previous ones or the position requires. Preferred candidate profile Bachelors degree in Life Sciences or Pharma or related health discipline. 5-8 years of research related experience in QA, pharmaceutical, biotechnology, or related industry Knowledge of GCP, ICH, GDPR or other applicable regulations Experience in GxP system validation, ISO 9001:2015; ISO 27001:2022; and/ or other Quality certifications Good computer skills (MS office applications) Good communication and collaboration skills. Orients and influences the people to meet the objectives, stimulates them to action and motivates them seeking maximum performance Good judgement, initiative, and a results-driven mindset Obtains and analyses relevant information, identifies causes and draws conclusions, achieves a complete knowledge of the operating environment.