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2 дня назад

Quality System Reviewer (F/M/X)

Формат работы
remote (только Belgium)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Belgium
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 System Reviewer (F/M/X) (cGMP/CAR-T): Reviewing nonconformities, risk assessments, and CAPA investigations for sterile CAR-T manufacturing facilities with an accent on quality systems compliance, regulatory documentation, and investigation coaching. Focus on assessing investigation quality, strengthening corrective and preventive actions, and ensuring adherence to cGMP, ICH guidelines, and safety requirements.

Location: Belgian facilities in Ghent and Beerse

Company

hirify.global is an independent technology consulting firm delivering consulting and engineering solutions across Information System & Digital, Telecom, Life Sciences, and Engineering.

What you will do

  • Review nonconformity risk assessments and end-to-end CAPA investigations against global and local procedures.
  • Collaborate with investigation teams, Quality members, and process stakeholders to ensure accurate and timely documentation.
  • Coach personnel on effective investigation and CAPA-handling practices.
  • Ensure activities comply with quality systems requirements and cGMP regulations for sterile manufacturing.
  • Monitor legal SHE compliance and report incidents, unsafe conditions, and environmental risks.
  • Contribute to prevention initiatives, accident investigations, and safety awareness campaigns.

Requirements

  • Master’s degree in a scientific or technical discipline, including analytics, chemistry, biotechnology, pharmaceutical sciences, or engineering, or equivalent experience.
  • At least 5 years of Quality Systems or Quality Assurance experience in manufacturing.
  • Strong knowledge of cGMP requirements for sterile manufacturing, ICH guidelines, and quality procedures.
  • Solid understanding of nonconformity and CAPA processes.
  • Analytical thinking, strong verbal and written communication, organisation, and teamwork skills.
  • Good command of English required. Proficiency in MS Office is expected.

Nice to have

  • Experience with COMET, Truvault, or SUMMIT.
  • Experience coaching personnel and supporting cross-functional teams.

Culture & Benefits

  • Long-term projects averaging more than 18 months with major international clients and support from internal Centers of Excellence.
  • Structured management support, regular project check-ins, and monthly HR communication.
  • Functional and geographic mobility across more than 60 countries.
  • AI initiatives, extensive training modules, and fully funded Microsoft certifications.
  • Health insurance, remote-work options, meal vouchers, a time savings account, and a referral bonus.

Hiring process

  • Brief virtual or phone call.
  • Approximately three interviews, adjusted to the role and seniority.
  • Possible case study, technical assessment, role play, or problem-solving exercise.

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