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6 дней назад

Analytical Method Validation Specialist (Pharmaceutical Quality Control)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Belgium
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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TL;DR
Analytical Method Validation Specialist (Pharmaceutical Quality Control): Coordinating and authoring analytical method validation documentation and studies within a GMP-regulated pharmaceutical manufacturing environment with an accent on validation protocols, technical reports, quality systems, and stakeholder coordination. Focus on analyzing validation results, maintaining the validated state of analytical methods, and supporting deviations, change controls, CAPA, and continuous improvement initiatives.

Location: Wavre, Belgium; onsite role

Company

Eurofins PSS Insourcing Solutions provides on-site scientific and quality services within client pharmaceutical manufacturing environments, using client facilities, equipment, and methodologies while maintaining GMP-compliant expertise.

What you will do

  • Author and maintain validation protocols, reports, amendments, risk assessments, scientific rationale reports, technical instructions, and periodic review documentation.
  • Prepare raw data review documentation, comparability protocols and reports, and QC material qualification documentation.
  • Coordinate validation activities, pre-tests, studies, data collection, experimental progress, and reporting across laboratories, statisticians, quality representatives, and project stakeholders.
  • Analyze validation results and ensure that outcomes are appropriately documented.
  • Support deviations, change controls, CAPA, investigations, peer reviews, and quality reviews linked to validation activities.
  • Contribute to analytical method lifecycle management, maintaining the validated state, and continuous improvement within QC Operations.

Requirements

  • Master’s degree in chemistry, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific discipline.
  • 3–5 years of experience in pharmaceutical Quality Control, Analytical Development, Validation, or Quality Assurance.
  • Strong experience with analytical method validation in a GMP-regulated environment.
  • Experience authoring technical and validation documentation.
  • Experience with change control, deviation management, and CAPA management.
  • Fluent English communication skills required.

Nice to have

  • French language skills.

Culture & Benefits

  • Permanent full-time contract of 40 hours per week, Monday to Friday.
  • Flexible start time between 7:00 and 9:30.
  • Meal vouchers worth €8 per working day and eco-cheques of approximately €250 per year.
  • DKV hospitalization insurance and 12 additional ADV days.
  • Well-being program, learning opportunities, additional training, team lunches, and team-building activities.

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