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6 дней назад

Manager QA (Pharmaceutical GMP)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Netherlands
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
Manager QA (Pharmaceutical GMP): Leading plant Quality Assurance staff and providing real-time quality oversight for pharmaceutical manufacturing operations with an accent on GMP compliance, batch documentation, investigations, and risk-based decision-making. Focus on approving deviations and CAPA records, supporting audits and inspections, resolving recurring quality events, and enabling timely batch disposition.

Location: Breda, Netherlands; on-site role

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines to patients worldwide.

What you will do

  • Lead and direct Quality Assurance staff supporting production operations during shifts, including resource planning, performance management, and staff development.
  • Provide real-time QA oversight and guidance to Production, Maintenance & Engineering, and Quality teams on quality standards and procedures.
  • Review and approve cGMP documentation, including deviations, CAPAs, electronic batch records, change controls, design qualifications, and SOPs.
  • Lead or support quality and compliance investigations, resolve operational issues, and alert senior management to quality, supply, compliance, and safety risks.
  • Participate in internal audits, regulatory inspections, and partner audits.
  • Drive Lean Transformation, Operational Excellence, continuous improvement, and reduction of recurring events; support batch review and disposition activities.

Requirements

  • Master of Science degree in Pharmacy or an equivalent qualification, or another Master’s degree supplemented with relevant pharmaceutical GMP experience.
  • Typically 2+ years of practical experience in clinical or commercial GMP manufacturing, warehousing, supply chain, equipment engineering principles, and validation.
  • Ability to solve problems and make scientific, risk-based decisions.
  • Strong written and verbal communication skills, including technical writing and presentations.
  • Ability to collaborate effectively with production and technical staff.

Nice to have

  • Knowledge and skills aligned with EU Directive 2001/83/EC Article 49 requirements for a Qualified Person.
  • Knowledge of GDP Guidelines 2013/C 68/01, Chapter 2.2, for a Responsible Person.
  • Ability to execute batch disposition or fulfill Qualified Person duties.

Culture & Benefits

  • Opportunities for professional development and career progression across a global organization.
  • Diverse and inclusive workplace where employees can contribute ideas and take action.
  • Competitive salary, bonus structure, fixed 13th-month payment, holiday allowance, and collective health insurance.
  • On-site gym, vitality program, and restaurant offering healthy food.

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