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Astellas Ireland Co., Ltd.

Temporary Regulatory Compliance Specialist

Astellas Ireland Co., Ltd.

  • Cork / Kerry / Limerick
  • Not disclosed
  • Temporary full-time
  • Updated 06/02/2013
  • Katie Larkin
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Description

Temporary Regulatory Compliance Specialist (Fixed - 12mths)

 

 

Temporary Regulatory Compliance Specialist

(Fixed Contract - 12mths)

  Main Responsibilities include but not limited to the following:

  • Ensuring that the dossiers submitted to the various regulatory authorities reflect activities in the plant and are compliant.
  • Ensuring compliance of all activities with GMP regulations (EU, FDA, Japan) within the Company and the Development of Regulatory Systems/Standard.
  • Tracking of variations and global change controls and ensuring that changes are reflected in the dossiers.  Relevant information must be shared with affected stake-holders. 

 

Requirements for the Position:

  • Excellent communication skills are essential to this role. The successful candidate must have proven ability to multi-task and to work under pressure.
  • Attention to detail and strong technical skills with ability to interpret data are essential to this role.
  • Strong knowledge and experience of pharmaceutical process (manufacturing & analytical).
  • QA/Regulatory experience is an advantage.
  • Third level degree  in a relevant scientific discipline.

 

Ref: RegComplianceDec12
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Astellas Ireland Co., Ltd.

Astellas Ireland Co., Ltd.

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