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Quality Systems & Validation Officer

Hikma Pharmaceuticals · Sintra

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Onsite 🇬🇧 English

Descrição do cargo

About the role

Join Hikma's Injectables Quality Systems Department to drive harmonisation of quality procedures, support validation projects and ensure regulatory compliance across multiple sites.

Key responsibilities

  • Drive and perform harmonisation of quality procedures and processes across the Injectables division.
  • Perform risk assessments of regulatory guidelines, internal procedures and quality systems.
  • Work on process improvements and monitor project progress across injectables sites.
  • Collect and track basic quality metrics, preparing simple reports and dashboards.
  • Conduct quality due diligences for new business opportunities.
  • Support audit preparation and execution, and assist in preparing audit reports and responses.
  • Provide validation support for new projects, including documentation revision.
  • Ensure departmental SOPs and related documentation are managed, controlled and compliant.
  • Update procedures and quality documents as required.
  • Monitor the training plan and act as Training Coordinator in the database.

Required profile

  • Degree in Pharmacy, Life Sciences, Engineering (Biochemistry, Biotechnology).
  • Strong organisational and documentation‑management skills.
  • Analytical mindset with ability to perform risk assessments and support problem‑solving.
  • Excellent communication and stakeholder‑engagement abilities.
  • Ability to work collaboratively in a cross‑functional, multi‑site environment.
  • Proactive approach to continuous improvement and operational excellence.
  • Attention to detail with a strong focus on compliance and quality.

Required skills

    What we offer

    • Direct contract with Hikma.
    • Competitive salary aligned with the role.
    • Life insurance.
    • Health insurance extended to student children (up to age 24).
    • Annual performance bonus.
    • Real growth opportunities.

    Questions fréquentes

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    Publicado há 23 horas

    Expira em 1 mês

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    Hikma Pharmaceuticals

    Sintra