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9 дней назад

Specialist QA (Pharmaceutical)

67 814 - 91 748
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Ireland
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
Specialist QA (Pharmaceutical) (GMP/GDP, SAP, LIMS): Managing batch disposition and quality records for contract manufacturers within a global supply quality function with an accent on cGMP documentation, investigations, and supplier-related changes. Focus on driving deviations and investigations to closure, reviewing complaint assessments, and maintaining compliance with manufacturing and distribution requirements.

Location: Dublin, Ireland

Salary: €67,813.85–€91,748.15 per year

Company

hirify.global operates a Global Supply Quality team supporting oversight and maintenance of contract manufacturers.

What you will do

  • Manage batch disposition activities in line with company quality standards.
  • Drive quality records, including deviations and investigation reports, to closure.
  • Initiate quality records for supplier-related changes and collaborate with the Complaints team on assessments and report reviews.
  • Provide data supporting quality management processes across the network.
  • Prepare, review, and approve SOPs and GMP/GDP documentation in accordance with corporate and regulatory requirements.
  • Contribute to quality improvement initiatives and communicate quality objectives and compliance needs to stakeholders.

Requirements

  • Master’s degree, or a Bachelor’s degree with 2 years of directly related experience, or an Associate’s degree with 6 years of experience, or a high school diploma/GED with 8 years of experience.
  • Deep knowledge of SAP and LIMS systems.
  • Experience with GMP software such as Veeva or TrackWise.
  • Basic understanding of supply chain and logistics processes.
  • Strong technical writing skills for cGxP documentation, including investigations, procedures, and change controls.
  • Ability to work independently, manage multiple priorities, and deliver accurate results on time.

Nice to have

  • 5+ years of quality and manufacturing experience in the biotech or pharmaceutical industry.
  • Bachelor’s degree in a science field and cGMP experience.
  • Familiarity with basic project management tools.
  • Understanding of API, drug substance, drug product, packaging, or device manufacturing and testing processes.
  • Experience working in a matrixed or team environment.

Culture & Benefits

  • Full-time role within a global supply quality function.
  • Collaboration with manufacturing, complaints, network, and other stakeholder groups.
  • Participation in operational and quality improvement programs and projects.

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