Qualification Engineer

1 maand geleden


Haarlem, Noord-Holland, Nederland Oxford Global Resources Voltijd
Job Title: Qualification Engineer

We are seeking a highly skilled Qualification Engineer to join our team at Oxford Global Resources. As a Qualification Engineer, you will play a crucial role in ensuring the validation and qualification of analytical chemical lab equipment in the pharmaceutical industry.

Key Responsibilities:
  • Lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Develop and execute validation protocols/plans for HPLC, GC-MS, UV-VIS, TOC, and FT-IR equipment.
  • Provide technical expertise and guidance on validation-related issues in project teams.
  • Collaborate with cross-functional teams to align validation activities with production schedules, project timelines, and quality expectations.
  • Review and assess validation data, deviations, and change controls to ensure compliance with regulatory requirements and internal quality standards.
Requirements:
  • Bachelor's or higher degree in a relevant scientific or engineering discipline.
  • Minimum 3 years of experience in validation/CQV in the pharmaceutical industry.
  • Knowledge of GMP and Good Documentation Practice (GDP).
  • Hands-on experience with HPLC/UV-VIS/GCMS/FTIR equipment.
  • Strong analytical, problem-solving, organizational, and project management skills.
What We Offer:
  • Competitive salary range.
  • Full-time position with standard business hours.
  • Temporary position with the possibility of extension.

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