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Capgemini

Global consulting, technology services, outsourcing

Analytical Development - Scientific Integrator

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeDiegem, Machelen, BelgiumNo salary listed

About the Job

Requirements

  • A degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline is required.
  • At least 5 years of experience in analytical development or quality within a pharmaceutical environment, with hands-on knowledge of small molecule analytical methods such as high-performance liquid chromatography and dissolution.
  • Strong understanding of regulatory frameworks, including International Council for Harmonisation Q6 guidelines, pharmacopoeial requirements, and Good Manufacturing Practice compliance, with experience in specification management and lifecycle management.
  • Proven ability to manage projects and communicate effectively with international and cross-functional stakeholders, including confidence in technical and scientific discussions.
  • Fluency in English and either French or Dutch.
  • Good mobility to Brussels and Beerse.

Responsibilities

  • Own and manage the full lifecycle of specifications for active pharmaceutical ingredients, raw materials, intermediates, and drug products, ensuring alignment with regulatory guidelines, compendia, and product registrations.
  • Lead global change management activities and drive company-wide harmonisation initiatives while continuously improving analytical processes.
  • Manage analytical activities including method development, validation, analytical method transfers, and quality investigations for marketed products.
  • Conduct technical assessments and scientific investigations related to the analytical control profile, including impurity management and compliance evaluations.
  • Support regulatory filings and respond to functional and technical queries, applying current analytical strategies in line with scientific excellence and client business strategy.
  • Collaborate with global stakeholders across supply chain, regulatory, and quality functions, and act as project leader for analytical and specification-related initiatives.

Desired Qualifications

  • A Master's degree or PhD in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline is preferred.
  • Experience with regulatory submissions and responding to agency queries is an advantage.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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