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13 дней назад

Sr. Associate IQA (Pharmaceutical Quality Assurance)

55 284 - 74 796
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Sr. Associate IQA (Pharmaceutical Quality Assurance): Inspecting and releasing primary and secondary packaging components for aseptic product manufacturing with an accent on incoming inspection, cGMP documentation, and quality investigations. Focus on sampling materials under Grade C conditions, managing CAPA and non-conformance activities, supporting audits, and driving continuous improvement.

Location: Dublin, Ireland; onsite 16/5 shift

Salary: €55,284–€74,796 per year

Company

hirify.global is a biotechnology company focused on developing and manufacturing medicines.

What you will do

  • Inspect and test primary and secondary packaging components used in aseptic product manufacturing.
  • Sample excipients and drug substances under Grade C conditions.
  • Review and approve component-testing documentation and cGMP records for disposition activities.
  • Compile, review, and approve minor non-conformances and CAPAs, ensuring root causes and implementation plans are addressed.
  • Participate in supplier complaint investigations, audits, training, SOP management, and continuous improvement initiatives.

Requirements

  • Must pass the required eye tests for visual inspection.
  • University degree, preferably in engineering or a science-related discipline.
  • At least four years of relevant experience in the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience.
  • Strong written and verbal communication, organizational, decision-making, and problem-solving skills.
  • Experience managing root-cause analysis, non-conformance, and deviation investigations.
  • Experience with aseptic operations, protein formulation, and vial or syringe filling is preferred.

Culture & Benefits

  • Work as part of a cross-functional Quality Assurance team reporting to a QA Manager.
  • Participate in site-wide continuous improvement and Operational Excellence initiatives.
  • Support staff through training and advice on component testing.
  • Perform all activities in accordance with hirify.global safety standards, policies, and SOPs.

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