Quality Assurance Professional

7 giorni fa


Saronno, Lombardia, Italia HR Executive - Ricerca e Selezione del Personale A tempo pieno

Our company, HR Executive - Ricerca e Selezione del Personale, is seeking a skilled Quality Assurance Professional to join our team. The ideal candidate will be responsible for ensuring the compliance of batches released documents and unlocking of batches using Oracle System.

The position will be inserted in the Regulatory Affairs team and reporting to the Regulatory, Pharmacovigilance and Quality Manager. Key responsibilities include:

  • Checking the compliance of batches released documents and unlocking of batches using Oracle System
  • Non-compliance management with the functions involved: Deviations, complaints and CAPAs etc
  • Collaborate with other business teams to ensure that compliance standards are maintained at all stages of projects
  • PQRs management according to internal procedure
  • Support to European Quality Team to provide its input for ongoing projects (e.g. nitrosamines project, gap analysis, etc.)
  • KPI's - Quality Dashboards preparation
  • Collaborate with the Regulatory and Logistics Departments in evaluating the communication of out of stocks in case of noncompliance
  • Keep the systems, files and archives under its responsibility updated in accordance with internal procedures
  • Management and Updating of the Quality Manual

The successful candidate will possess:

  • A degree in scientific disciplines
  • Matured experience in multinational pharmaceutical and commercial companies, minimum of 2/3 years of experience in QA - RA Compliance or comparable roles
  • Knowledge of ICH and GxP standards (GMP=Good Manufacturing Practices/GDP=Good Distribution Practices) principles
  • Knowledge of Module 3 of the registration dossier
  • Good knowledge of IT tools, particularly Office, Oracle knowledge is a plus
  • Fluent English
  • Strong interpersonal, communication, negotiation, influencing, and problem-solving skills, including the successful implementation of continuous improvement initiatives

We offer a permanent contract in an international and growing context.



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