quality assurance officer

2 settimane fa

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

Our customer is the Italian Branch of a multinational Company leader in the production of equivalent drugs (ethical and hospital) and consumer products. The italian branch is active in the distribution of its products to Pharmacies and Hospitals channel.

We have been charged to recruit the following professional figure:

QUALITY ASSURANCE OFFICER

The position will be inserted in the Regulatory Affairs team and reporting to the Regulatory, Pharmacovigilance and Quality Manager will take care of the following activities:

  • Checking the compliance of batches released documents andunlocking 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 thecompliance 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.

Skills to cover the position:

  • Degree in scientific disciplines
  • Experience matured 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, complete the profile

The company offers insertion with a permanent contract in an international and growing context.

Job site: North- West Milan

To apply to the offer, we invite interested people (L.903/77) to send their detailed curriculum to: specifying their consent to the processing of personal data (DL196/03) and ref. MM 139 in the subject of the email.

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