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Sede

Rieti

Settore funzionale

Produzione

Descrizione

POSITION: COMPLIANCE COORDINATOR

LOCATION: RIETI

ABOUT THE ROLE:

  • Support the change management process with Regulatory affairs and local authority impact.

  • Support Reg CMC dossier and variations issuing and tracking

  • Support self, internal, and authorities GMP inspections

HOW YOU WILL CONTRIBUTE:

  • Support the preparation of AIFA documentation and communication as per follow up questions or actions for essential and not essential modification to the Manufacturing License.

  • Support the drafting of the variations of eCTD Module 3 (Quality) as per company project plans and related CMC changes and MoH questions.

  • Support the alignment process of internal documentation to the eCTD and GMP requirements.

  • Support regular GMP or Pre-Approval Inspections conducted by internal auditor and/or Authorities

  • Collaborate to Risk Management process for facility changes

  • Collaborate in management of License Information (LI) and Post market Commitments (PMC)

WHAT YOU BRING TO TAKEDA

  • Knowledge of European and US cGMP  Regulations and Pharmaceutical Quality System

  • Good written and spoken English

  • Knowledge of DLg 219

  • Microsoft Office tools and Informatics Systems

Desired: 3-5 years of experience in Pharmaceutical Quality System/Quality Assurance and/or in plasma manufacturing process.  Regulatory Master degree.

Leadership & Behaviors

  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be team working oriented

Degree in Chemistry / Biochemistry / Biology or equivalent scientific disciplines. Good written and spoken English language.


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