Quality Operations Regulatory Specialist
Human Value

The Company

Our Client is a prestigious multinational company leader in the pharmaceutical sector. The company, solid and very innovative, is going through a phase of strong investments that will strengthen its leadership position in the reference market.
In order to strengthen one of the Italian plants, located in the area of Frosinone, we are looking for a Quality Operations Regulatory Specialist.

The Role

Reporting to the Quality Manager of the specific Business Unit dedicated to Biological and sterile production, the Quality Operations Regulatory Specialist will manage the following activities:
  • Grant correct management of the GMP site documentation and information to assure compliance with registration files
  • Liaise with site and global functions, and customers for communications and management of issues related to regulatory activities and information
  • Draft the registration documentation of the site addressed to Authorities and customers according to the legislation and Quality Agreements
  • Assess with the laboratory, the specifications and analytical methods to make effective changes to the registration files
  • Liaise with site and global functions to provide regulatory assessment for new project and product introduction
  • Issue certificates of compliance and analysis
  • Prepare and submit AIFA and MoH notifications of changes
  • Update Site Master File
  • Support the site “Regulatory Intelligence”
  • Support the site stability program
  • Support external inspection/audit from Health Authorities and customers

The Requirements

  • Degree in Scientific Disciplines (mainly Pharmaceutical Sciences)
  • Minimum 3 years of experience in Regulatory Compliance and/or System Compliance  in pharmaceutical industry
  • A good background within Biological and sterile production will be crucial
  • Advanced in computer skills such as MS Office and good knowledge of enterprise system (SAP, TrackWise, LIMS)
  • Fluent in written and spoken English
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Chimico, farmaceutico

Industria & Artigianato/Qualità

da 3 a 5 anni

Tempo indeterminato

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