Qualified Person

i-Pharm Consulting

Amsterdam

On-site

EUR 110,000 - 160,000

Full time

45 hours ago
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Benefits offered by this job

Relocation support

Job summary

i-Pharm Consulting partners with a leading pharmaceutical manufacturer to recruit a Qualified Person (QP) for the Netherlands. You will certify and release medicinal products, ensuring EU GMP compliance, Marketing Authorisations, and internal quality standards, collaborating across Quality, Manufacturing, Regulatory Affairs and Supply Chain.

Eligible QPs from Europe who can relocate to the Netherlands are invited to apply.

Qualifications

  • Eligible to act as a Qualified Person in the Netherlands under EU Directive 2001/83/EC.
  • Proven experience as a QP in GMP-regulated pharmaceutical manufacturing.
  • Experience certifying and releasing medicinal products under a manufacturing licence.
  • Strong understanding of EU GMP requirements, batch certification, quality systems, and regulatory compliance.
  • Experience in sterile manufacturing, solid dose, generics, oncology, or similar environments is highly desirable.
  • Ability to make quality-critical decisions with integrity; strong stakeholder management and communication skills.
  • Professional proficiency in English.

Responsibilities

  • Perform QP certification and batch release activities per EU GMP and applicable regulations.
  • Certify and release medicinal products ensuring compliance with MA and quality standards.
  • Review batch documentation, deviations, investigations, CAPAs, change controls, and quality records.
  • Provide GMP and QP guidance to cross-functional teams.
  • Support regulatory inspections, audits, and inspection readiness.
  • Drive continuous improvement across quality systems and manufacturing operations.
  • Support growth by enabling timely release of medicines to patients worldwide.

Skills

QP experience
EU GMP knowledge
Quality systems
Regulatory compliance
Stakeholder management
English proficiency

Education

EU Qualified Person status (QP)

Job description

  • Are you an EU Qualified Person looking to take the next step in your career with a rapidly expanding pharmaceutical company?
  • Do you have experience certifying and releasing products within sterile manufacturing, generics, solid dosage forms, or oncology environments?
  • Would you be open to relocating to the Netherlands to join a business experiencing exceptional growth and expansion?

If so, we'd love to speak with you.

We are partnering with a highly successful pharmaceutical manufacturer that has enjoyed a phenomenal period of growth over the past year. With an expanding product portfolio, a growing development pipeline, and increasing manufacturing activity, the organisation is continuing to invest heavily in its Quality function to support future success.

As a result, they are seeking an experienced Qualified Person (QP) to join their team on a permanent basis in the Netherlands. This is a unique opportunity to become part of a business where Quality has a genuine strategic voice and where your work directly contributes to ensuring critical medicines reach patients safely and efficiently.

The company welcomes applications from Qualified Persons across Europe who are eligible to act as a QP in the Netherlands and are open to relocation.

About the Role

As a Qualified Person, you will be responsible for the certification and release of medicinal products, ensuring compliance with EU GMP requirements, Marketing Authorisations, and internal quality standards.

Working closely with Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Technical Operations teams, you will play a pivotal role in supporting the continued expansion of the business while maintaining the highest standards of quality, compliance, and patient safety.

This role offers exposure to a diverse portfolio of products and the opportunity to support the release of an increasing number of products as the organisation continues to grow.

Key Responsibilities
  • Perform QP certification and batch release activities in accordance with EU GMP requirements and applicable regulations.
  • Certify and release medicinal products while ensuring full compliance with Manufacturing Authorisations, Marketing Authorisations, and company quality standards.
  • Review and assess batch documentation, deviations, investigations, CAPAs, change controls, and associated quality records.
  • Provide expert GMP and QP guidance to cross-functional teams across the organisation.
  • Support regulatory inspections, customer audits, and internal quality audits, ensuring ongoing inspection readiness.
  • Drive continuous improvement initiatives across quality systems and manufacturing operations.
  • Act as a key quality stakeholder, ensuring patient safety and product quality remain at the forefront of all decision-making.
  • Support the organisation's continued product growth and expansion by enabling the timely release of medicines to patients worldwide.
What We're Looking For
  • Eligible to act as a Qualified Person in the Netherlands in accordance with EU Directive 2001/83/EC.
  • Proven experience operating as a QP within a GMP-regulated pharmaceutical manufacturing environment.
  • Experience certifying and releasing medicinal products under a manufacturing licence.
  • Strong understanding of EU GMP requirements, batch certification, quality systems, and regulatory compliance.
  • Experience within sterile manufacturing, solid dose, generics, oncology, or other complex pharmaceutical manufacturing environments is highly desirable.
  • Ability to make quality-critical decisions with confidence and integrity.
  • Strong stakeholder management and communication skills.
  • Professional proficiency in English.
  • Candidates based anywhere within the EU who are willing to relocate to the Netherlands are encouraged to apply.
Why Join?
  • Join a pharmaceutical company experiencing significant and sustained growth.
  • Be part of an expanding Quality organisation with strong executive support and investment.
  • Work with a growing portfolio of established and pipeline products.
  • Play a critical role in helping bring medicines to patients globally.
  • Collaborative, quality-driven culture with long-term career development opportunities.
  • Competitive salary, benefits package, and relocation support where applicable.
  • Opportunity to make a meaningful impact in an organisation entering an exciting phase of growth and transformation.

If you're a Qualified Person eligible to work in the EU with experience in sterile products, solid dose, generics, or oncology manufacturing and are interested in joining a high-growth pharmaceutical company in the Netherlands, I'd be delighted to discuss the opportunity further.

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