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QA Specialist - Pharma (GMP)

  • Locatie:

    Leiden, Nederland

  • Contactpersoon:

    Nicol Heijtbrink

  • Contractsoorten:

    Temp to Perm

  • Telefoon contactpersoon:

    +31 (0)20 406 97 50

  • Bedrijfssectoren:

    Pharmaceutical , Life Sciences

  • E-mail contactpersoon:

    Nicol_heijtbrink@oxfordcorp.com

We are now looking for an enthusiastic pharmaceutical QA specialist. Are you experienced with change controls, documentation and validations in a pharmaceutical or bio-technical industry? Then we are looking for you!

Job Description

Within the quality assurance department you will focus on operational commercial products. As QA specialist you are responsible for compliance to GMP and overall quality support for commercial products. Day-to-day activities include CAPA's, non-conformance management, validation protocols and lifecycle documentation. Furthermore, in this dynamic position, you might also be tasked with process improvements and project changes. In close collaboration with other departments including operations, QC and RA, you assure everything is implemented according to cGMP guidelines and other quality management systems.

Responsibilities

  • A variety of QA tasks, ensure all work is up to cGMP standards;
  • Review and approve change controls;
  • Draft validation protocols and reports and evaluate validation assessments;
  • Write lifecycle documentation;
  • Pro-active monitoring of changes to ensure timely schedules;
  • Collaboration with manufacturing, quality control, engineering and regulatory affairs;
  • Implement new technologies and process improvement;
  • Provide long term vision on how to meet future demands;


Requirements

  • Bsc or HBO in bioscience, chemistry or pharmacy;
  • 2 years QA experience in pharmaceutical industry;
  • Up to date knowledge of cGMP regulations;
  • Applicants must have experience with documentation and chance control;
  • System validation experience and CSV;
  • When applying please show experience with documentation systems;
  • Good command of Dutch and English language, only English speaking candidates will not be considered;
  • Communicative and a problem-solving mindset;


Benefits

  • Contract: start through Oxford, possibility for extension;
  • Salary: €3000- €4500 gross monthly based on education/ experience;
  • Holidays: 25;
  • Working hours: full-time, 32 hours possible;
  • Region: Leiden
  • Vacancy number: 19120