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Astellas Ireland Co., Ltd.

QA Specialist - Kerry Plant

Astellas Ireland Co., Ltd.

  • Cork / Kerry / Limerick
  • Not disclosed
  • Fixed term contract
  • Updated 08/02/2013
this job is expired
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Temporary QA Specialist - (Kerry)


QA Specialist - (Fixed Contract)




This position involves day-to-day QA production activities, production batch documentation review, execution of line clearances, document initiation request / document change request review, on-line quality impact assessments, participation in quality risk assessments, support problem solving, internal/external auditing, house-keeping inspections, customer compliants and project work, as required. The position will also involve the assessment of compliance with GMP regulations (EU, FDA, Japan) within the Company and the Development of Regulatory Systems/Standards. Coaching and advising line operating personnel on compliance requirements and best practice is a daily requirement.


Qualifications and experience:

Third level degree in a relevant scientific discipline.

Quality Assurance and Compliance experience in a pharmaceutical environment is essential.

Knowledge of Trackwise would be an advantage.

The successful candidate must have excellent communication skills, proven leadership skills, report writing skills, good attention to detail and also be a team player, including cross functional teams.

Shift work is a requirement of this position

Ref: QA14012013
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Astellas Ireland Co., Ltd.

Astellas Ireland Co., Ltd.

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