Quality Investigation Specialist

Quality Investigation Specialist for pharmaceutical manufacturing, supporting USP and DSP operations, based in Leiden, Zuid-Holland, Netherlands.

Locatie
Leiden
Sluitingsdatum

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Eisen

  • Relevant BSc or MSc in a scientific or technical discipline
  • Ability to work independently and collaboratively across teams
  • Basic understanding of manufacturing operations, ideally USP and/or DSP
  • Hands-on experience with QMS, deviations, CAPAs, non-conformances, and change control
  • Strong technical writing and documentation skills
  • Strong analytical, problem-solving, and stakeholder management skills
  • Excellent English communication skills
Volledige omschrijving

A leading organization in the pharmaceutical manufacturing sector, committed to maintaining the highest standards of quality and compliance. The company values innovation, teamwork, and a proactive approach to continuous improvement. We are looking for Quality Engineers to support Upstream Processing (USP) and Downstream Processing (DSP) operations within a pharmaceutical or biotechnology manufacturing environment. In this role, you will work closely with Operations, Engineering, MSAT, and QA to manage quality issues, ensure compliance, and support continuous improvement.

Both junior and senior candidates are welcome.

Key Responsibilities: Manage deviations and non-conformances. Support and manage CAPAs (Corrective and Preventive Actions). Handle change control processes. Perform root cause analysis, including Fishbone Analysis. Prepare and review technical quality documentation. Maintain quality processes within the Quality Management System (QMS). Collaborate with Operations, Engineering, MSAT, and QA. Support manufacturing quality and compliance activities.

Requirements: Relevant BSc or MSc in a scientific or technical discipline. Hands-on experience with QMS, deviations, CAPAs, non-conformances, and change control. Basic understanding of manufacturing operations, ideally USP and/or DSP. Strong technical writing and documentation skills. Excellent English communication skills. Strong analytical, problem-solving, and stakeholder management skills. Ability to work independently and collaboratively across teams.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

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Quality Investigation Specialist

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