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Senior QA Manager in ACINO Ukrayina

Posted more than 30 days ago

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ACINO Ukrayina

ACINO Ukrayina

0
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Without experience
Kyiv
Full-time work
Requirements to candidates: Higher pharmaceutical / biotechnological educationWork experience in a similar position for at least 2 yearsRegulatory legislation of Ukraine for the pharmaceutical industryGuidelines and Directives of the European Union (GMP, GDP)Policies of the World Health Organization (WHO)Guidelines of the International Convention on Harmonization (ICH)Personnel management skills English on upper-intermediate level Main responsibilities: Management of Quality System at region lev

Requirements to candidates:

 Higher pharmaceutical / biotechnological education

  • Work experience in a similar position for at least 2 years
  • Regulatory legislation of Ukraine for the pharmaceutical industry
  • Guidelines and Directives of the European Union (GMP, GDP)
  • Policies of the World Health Organization (WHO)
  • Guidelines of the International Convention on Harmonization (ICH)
  • Personnel management skills 
  • English on upper-intermediate level

 Main responsibilities:

 Management of Quality System at region level (UA+CIS)

  • KPI reporting, Annual Management Review preparation
  • Monitoring and timely updating of the QMS documentation (SOPs, Quality Manual, Dossier of Importer, ext.)
  • Planning and carrying out self-inspections at local and region level
  • CAPA management
  • Host HA inspections, customer audits
  • Quality risk assessment, analysis, and management
  • Change control management
  • Assessment of Product Quality Review protocols
  • Carrying out training for company's employees on compliance with GxP 
  • Oversight of complaint and deviation management
  • Management of Quality issues including escalation to the Company management  

Company provides competitive salary and international working environment

Corporate car is a part of compensation package.  

Without experience
Kyiv
Full-time work
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