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4 дня назад

QA Specialist (Pharmaceutical)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Singapore
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
QA Specialist (Pharmaceutical): Reviewing and approving GMP documentation, batch records, deviations, and quality systems for intermediates and active pharmaceutical ingredients with an accent on regulatory compliance, inspection readiness, and product quality. Focus on investigating root causes, evaluating corrective and preventive actions, maintaining validated GMP processes, and identifying quality trends.

Location: Singapore – Tuas; on-premise

Company

hirify.global develops and manufactures pharmaceutical products, including intermediates and active pharmaceutical ingredients, under strict quality and regulatory standards.

What you will do

  • Review and approve master and completed batch records for the manufacture, packaging, and labelling of intermediates and active pharmaceutical ingredients.
  • Perform product disposition and review cleaning instructions, GMP documents, SOPs, protocols, reports, and change controls.
  • Review deviations, investigation reports, root cause analyses, corrective and preventive actions, and quality impact assessments.
  • Maintain quality tracking systems and metrics, support annual product reviews, and identify trends and atypical observations.
  • Maintain inspection readiness, support regulatory and customer inspections, and help preserve the validated state of GMP systems and processes.
  • Contribute to quality improvement, regulatory submissions, Value Stream Team activities, and EHS investigations.

Requirements

  • Diploma with at least 4 years of relevant experience, or BA/BS with at least 1 year of relevant experience.
  • Experience in the pharmaceutical industry and quality administration systems.
  • Sound knowledge of current Good Manufacturing Practices and GxP.
  • Effective written and oral communication skills in English.
  • Ability to work effectively within cross-functional teams.

Nice to have

  • Manufacturing-site experience.
  • Experience managing and writing deviations, reviewing production batch records, and investigating non-conformances.
  • Experience with enterprise resource planning systems, root cause analysis, and change control management.
  • Strong problem-solving, time-management, multitasking, and independent-working skills.
  • Experience using generative AI tools such as Microsoft Copilot.

Culture & Benefits

  • Quality-focused environment rooted in science and risk-based compliance.
  • Collaboration across Value Stream Teams and interdepartmental groups.
  • Opportunities to support continuous improvement, safety initiatives, and regulatory inspection readiness.
  • On-premise work at the Tuas site.

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