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30.12.2019

QA Change managers

Acino
Фармацевтика
  • Регион:Киев
Английский (продвинутый)

Job description:

 

  • Provide administration of change management. You are direct responsible to drive and coordinate all brand related regulatory relevant change requests and master data maintenance.
  • Ensure timely implementation of all on-going life-cycle activities (change requests); drive the evaluation and coordinate such change requests.
  • Liaise with country managers, regulatory affairs department, business process owners and customers to facilitate working out and implementation of change requests.
  • Participate in issuing and reviewing registration dossier and actively support in addressing HA deficiency letters.
  • Ensure internal policies/processes are consistently applied proactively.

 

Profile:

  • Scientific academic background, preferably in pharmacy, biology or chemistry.
  • Previous experience in pharmaceutical companies is a must (minimum 3 years).
  • Well organized person and capable of managing multiple projects, excellent time management with respect to priorities and self-management.
  • Ability to work independently and pro-actively.
  • English writing/oral skills is a must. German is a plus.

 

Company offers a unique opportunity to gain international experience!