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About the company:

If you feel like you’re part of something bigger, it’s because you are. Their, shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

About the role:

  • Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
  • Review and approve batch production record data entries before production activities take place
  • Perform finished product checks during (commercial) production runs
  • Compile and review batch records for lots assembled, packaged and labeled at ABR and contract manufacturers in preparation for disposition by QP.
  • Review of operational SOP’s and Work Instructions
  • Approve Maximo Work Orders
  • Perform GMP compliance checks in production
  • Assist in development and delivery of GMP training activities for QA and production staff
  • Assist in ABR projects and improvement efforts as needed
  • Responsible for preparation of weekly/monthly metric
  • Operate in shifts

Qualifications

  • MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
  • 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
  • Manufacturing and/or Quality analytical processes and operations.
  • Fluent in English language. Dutch is Preferred.
Interested? Then do not hesitate to click on apply button to know more about this role.