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Release Specialist

Coloplast · Felgueiras

🇬🇧 English
Sterilization GMP GDP DMR QC CoC COA Quality assurance

Job description

About the role

Coloplast is seeking a Release Specialist to join the new manufacturing site for its Continence Care segment. The role ensures that sterile products meet the highest quality standards before they reach the market and our users.

Key responsibilities

  • Support and promote a quality‑first culture across the site.
  • Lead, execute and document sterile release activities and quality control tests.
  • Approve documentation related to the work area, including DMR, QC records, CoC and COA.
  • Train and guide staff on sterile release procedures.
  • Partner with production to address changes, troubleshoot deviations and drive continuous improvement.
  • Own non‑conformities related to sterilization and manage corrective actions.
  • Participate in launch projects and solve technical process problems.
  • Serve as the primary point of contact for the sterilization site.

Required profile

  • B.Sc. or higher in a relevant scientific or engineering discipline.
  • Minimum 2 years experience in sterilization, quality assurance or a similar production environment.
  • Strong understanding of GMP, GDP and related certification requirements.
  • Familiarity with production documentation such as DMR, QC, CoC and COA.
  • Holistic view of end‑to‑end manufacturing processes.
  • Fluent written and spoken English.

Required skills

  • Sterilization processes
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Production documentation (DMR, QC, CoC, COA)
  • Quality assurance and control

What we offer

  • Opportunity to shape quality processes at a new manufacturing site.
  • Inclusive work environment that values diversity.
  • Career growth within a global medical‑device leader.

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Published 4 months ago

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Coloplast

Felgueiras