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8 дней назад

Batch Release Lead Qualified Person (Biopharma)

73 200 - 97 600€
Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
c1
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
Batch Release Lead Qualified Person (Biopharma): Certifying and releasing sterile pharmaceutical batches in compliance with cGMP requirements, while overseeing quality systems and site-wide improvement initiatives with an accent on Annex 1 compliance, quality documentation, and batch certification. Focus on investigating product issues, resolving quality actions, mentoring QA specialists, and ensuring safe, timely product release.

Location: Waterford, Ireland; 3 days onsite and 2 days remote per week. Candidates must be based in Ireland.

Salary: €73,200–€97,600 per year.

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

  • Certify and release sterile pharmaceutical batches while ensuring compliance with cGMP requirements.
  • Review and approve quality documentation and investigate product issues before release.
  • Collaborate with cross-functional teams to resolve quality issues and close corrective actions.
  • Lead site-wide quality process improvement projects.
  • Guide and mentor QA specialists and support their professional development.
  • Follow site safety procedures and escalate safety concerns.

Requirements

  • Previous experience as a Qualified Person certifying and releasing batches under a manufacturing licence.
  • Experience with sterile product manufacturing and current regulatory requirements, including Annex 1.
  • Master’s degree or Pharmacy qualification meeting Qualified Person eligibility criteria through an Ireland-based qualification or UK equivalent.
  • Fluent English and current residence in Ireland required.
  • Strong communication, influencing, follow-through, and results-oriented skills.
  • Ability to work onsite according to production schedules is required.

Culture & Benefits

  • Work with AI, robotics, digital technologies, and next-generation automation in pharmaceutical manufacturing.
  • Contribute to smart factory, resilient supply chain, and new product launch initiatives.
  • Develop skills and explore cross-functional opportunities in a growth-oriented environment.
  • Participate in employee benefit programs.
  • Equal-opportunity and disability-confident workplace.

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