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5 часов назад

Regional Qualification Senior Specialist (Pharma)

7 603 200 - 11 404 800HUF
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Hungary
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Regional Qualification Senior Specialist (Pharma): Writing, reviewing, and tracking qualification reports for manufacturing facilities, utilities, and equipment in a GxP-regulated pharmaceutical environment with an accent on data integrity, regulatory compliance, and cross-functional collaboration. Focus on interpreting qualification data, assessing deviations and change controls, and improving equipment qualification processes through standardization, simplification, and digitalization.

Location: Budapest, Hungary; hybrid working

Salary: Ft7 603 200,00–Ft11 404 800,00

Company

hirify.global is a global life sciences and pharmaceutical company developing healthcare solutions across vaccines, rare diseases, oncology, immunology, diabetes, and other therapeutic areas.

What you will do

  • Write qualification and requalification protocols and reports for manufacturing facilities, utilities, and equipment.
  • Collect and analyze site data, checking parameters, operating conditions, acceptance criteria, data integrity, and quality requirements.
  • Work with subject-matter experts to review results and determine whether study objectives have been met.
  • Assess deviations and change controls that may affect the qualified status of facilities, utilities, or equipment.
  • Prepare findings and conclusions while ensuring compliance with FDA, EMA, GxP, and company quality standards.
  • Coordinate with regional manufacturing sites, global and regional hubs, and project teams; support continuous improvement and digitalization initiatives.

Requirements

  • Professional experience in the pharmaceutical industry and a GxP-regulated environment.
  • Bachelor’s degree, preferably in engineering, pharmacy, chemistry, biology, or a related field.
  • Experience with quality systems such as Veeva or Kneat, as well as Word, Excel, and PowerPoint.
  • Strong analytical, problem-solving, organizational, and collaboration skills.
  • Excellent English communication and writing skills required.
  • Ability to work proactively and adapt to complex and dynamic environments.

Nice to have

  • French, German, Italian, or Hungarian language proficiency.
  • Experience translating manufacturing data packages.

Culture & Benefits

  • Hybrid work in the Budapest Hub.
  • Participation in a global manufacturing and supply services organization.
  • Opportunities to contribute to standardization, simplification, and digitalization of qualification processes.
  • Eligibility for company employee benefit programs.
  • Equal-opportunity workplace with a focus on inclusion and collaboration.

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