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ACINO Україна — вакансия в Change control manager (GMP-pharma)
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Change control manager (GMP-pharma)

ACINO Україна
3 месяца назад
29 мая 2023
Киевул. Воловаська 10/14

Basic requirements:

  • Scientific academic background, preferably in pharmacy, biology or chemistry
  • Sufficient experience in the pharmaceutical industry in R&D, QA, production, RA
  • Well organized person and capable of managing multiple projects, excellent time management with respect to priorities and self-management
  • Ability to work pro-actively 

Job Description:

  • Provide administration of change management
  • Drive and coordinate all product related changes (with or without regulatory relevance) and maintain relevant data
  • Ensure timely implementation of all on-going product life-cycle activities
  • Liaise with country managers, regulatory affairs department, business process owners and clients to facilitate working out and implementation of changes
  • Participate in preparation, reviewing and issuing production, QA, QC, registration documentation
  • Actively support in addressing health authorities deficiency letters
  • Cooperation and support in quality inspections/audits including their follow-up actions
  • Provide investigation of compliance related deviations
  • Implementation of quality improvement projects
ACINO Україна — вакансия в Change control manager (GMP-pharma): фото 2

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