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Validation Specialist - HPLC

We are looking for a technical specialist with experience with chemical separation techniques in pharmaceutical industry.

Job description

You will be part of the team responsible for the execution of all analytical testing methods. In this position you are the Subject Matter Expert (SME) chemical separation techniques (HPLC). As technical specialist you are mostly responsible for handling QA and compliance matters such as: Validations, Deviations, CAPA's and change control.

Responsibilities

  • Deviation management; lead investigator for non-conformances and applying the correct preventive and corrective actions.
  • Responsible for quality issues, lab investigation and CRA's.
  • Leading continuous improvement processes.
  • Expert in separation techniques such as HPLC, represent the team during meetings.
  • GAP analysis, writing reports and protocols.

Profile

  • BSc or MSc in bioscience, pharmacy or biochemistry. (PhD is overqualified).
  • Medior to Senior level experience in (bio)pharmaceutical industry.
  • Knowledge of physical and chemical separation techniques for vaccine development.
  • Proven excellent knowledge on GMP-guidelines.
  • Good technical writing skills in English.
  • You have a valid working permit for the Netherlands.

Terms of employment

  • One-year temporary project trough Oxford Global Resources.
  • Salary indication: from 3000 to 5000 gross per month
  • Working hours: fulltime
  • Location: Leiden region

Vacancy number: 16003