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7 дней назад

Quality Assurance QA Specialist

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
Quality Assurance QA Specialist (Pharmaceutical Manufacturing/GMP): Ensuring compliant batch review, batch release, validation, deviation management, and CAPA execution for pharmaceutical manufacturing operations with an accent on regulatory compliance, investigation quality, and continuous improvement. Focus on leading complex root cause investigations, approving batch disposition decisions, reviewing qualification and validation documentation, and resolving shopfloor quality issues.

Location: City of Singapore; onsite quality operations role

Company

hirify.global is a pharmaceutical company focused on developing and manufacturing medicines and improving health outcomes.

What you will do

  • Review and approve batch records and associated documentation, and oversee batch disposition and release.
  • Ensure batch release, qualification, and validation activities comply with GMP, regulatory requirements, and company quality standards.
  • Lead and review complex deviation and laboratory investigations, including scientifically justified root cause analysis.
  • Monitor CAPA progress, batch release performance metrics, and continuous improvement initiatives.
  • Participate in audits, regulatory inspections, GEMBA walk-downs, quality meetings, and manufacturing issue resolution.
  • Develop risk management and remediation actions while promoting a quality-focused culture across the organization.

Requirements

  • Engineering or science degree, or an equivalent combination of education and relevant experience.
  • 3–5 years of quality operations experience in the pharmaceutical industry or an equivalent environment.
  • Experience in batch release, deviation management, and investigations is preferred.
  • Strong attention to detail, time management, independent working ability, and report writing or review skills.
  • Effective verbal, written, interpersonal, and presentation skills with the ability to collaborate cross-functionally.
  • Proactive, adaptable, and assertive approach to quality-related decision-making and changing manufacturing priorities.

Culture & Benefits

  • Full-time role supporting site manufacturing and quality operations.
  • Commitment to GMP compliance, health and safety, continuous improvement, and a Zero Incident Mindset.
  • Equal-opportunity workplace with an emphasis on diversity, equity, and inclusion.

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