Senior Associate QA | English

2 weken geleden

Eindhoven, Nederland Undutchables Voltijd
As a Senior Associate QA, you will support product quality through compliance management, collaboration with partners, and act as a subject matter expert on distribution quality processes. It’s an As a Senior Associate QA, you will support product quality through compliance management, collaboration with partners, and act as a subject matter expert on distribution quality processes. It’s an opportunity to make a meaningful impact within a team dedicated to delivering life-changing therapies worldwide.
Key Responsibilities:
  • Act as QA representative for non-conformance, change management, CAPAs, verification, and documentation; ensure end-to-end compliance with GMP/GDP standards.
  • Serve as a subject matter expert (SME) for quality processes related to transportation.
  • Review and approve SOPs and GMP/GDP documentation, ensuring alignment with corporate, regulatory, and compliance standards.
  • Collaborate with third-party providers to maintain service levels and identify improvements under the READ (Reliability, Efficiency, Agility, Differentiation) framework.
  • Incorporate risk management strategies into broader supply chain processes.
  • Perform comprehensive reviews of GMP processes, including deviations, CAPAs, change controls, and validations.
  • Support oversight of logistics and transportation providers.
  • Assist with internal and external audits and inspections, participating as part of the audit team.
  • Provide QA assessments of operations, supporting quality-focused initiatives and cross-functional collaboration.
  • Lead and participate in projects aimed at enhancing operational efficiency and quality.
  • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance.
  • In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance.
  • Familiarity with logistics, including parcel handling, transportation, and warehousing.
  • Background in process, equipment, and facility validation/qualification.
  • Strong skills in technical writing.

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