OOS/Exception Specialist

3 weken geleden

Leiden, Zuid-Holland, Nederland Eurofins Netherlands BioPharma Product Testing Voltijd
Job Description

As an OOS/Exception Specialist at Eurofins Netherlands BioPharma Product Testing, you will play a crucial role in supporting our QC Analysts in the follow-up of deviation results in the QC laboratory. Your primary responsibility will be to investigate and resolve unexpected testing results or irregularities in the primary testing process.

We are seeking an experienced Analyst or OOS Specialist with a strong background in troubleshooting deviating lab results. The ideal candidate will have a solid understanding of GMP guidelines and regulations, as well as excellent communication and organizational skills.

Key Responsibilities:
  • Immediate troubleshooting of unexpected testing results or irregularities in the primary testing process.
  • Decision making to open an Exception – or OOS record in eLIMS, in agreement with department management and QA.
  • Client notification and follow-up communication (if required) in the case of a client-specific OOS or critical Exception in agreement with QC review, QA, and relevant client-specific Quality Agreement.
  • Leading the investigation in cooperation with relevant stakeholders and clients (if needed) and applying root cause analysis tools.
  • Proposing (re)testing plans and gathering approvals from QA and clients (if required).
  • Proper technical writing and finalization of exceptions within due dates and in-line with expectations from QA policy, GMP guidelines, and applicable regulations.
  • Proposing and implementing CAPAs in cooperation and agreement with the responsible department and QA.
  • Executing (re)training of involved staff as part of the OOS – or Exception investigation where needed.
Requirements:
  • Completed a BSc or MSc education in Biopharmaceutical Sciences, such as Chemistry, Biology, or a similar discipline.
  • At least 3 years of work experience in deviation management.
  • Working experience according to GMP (Good Manufacturing Practices) in the (bio)pharmaceutical industry.
  • Good command of the English language orally and in writing is required. Dutch is considered a plus.
  • Excellent communications and organizational skills to interact with clients and internal stakeholders.
  • Flexible mindset in order to work effectively in a dynamic environment.
  • A responsible, analytical, and pro-active attitude to resolve the OOS and Exceptions in a tight timeframe.
  • You are located in the Netherlands, or you are planning to relocate to the Netherlands and are in possession of a valid work permit.
About Eurofins Netherlands BioPharma Product Testing:

We are a leading provider of analytical testing services to clients across multiple industries. Our team is dedicated to delivering high-quality results and exceptional customer service. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development.

As an OOS/Exception Specialist, you will be part of a close-knit team where collegiality and collaboration come first. We offer a competitive salary, flexible working hours, and a range of benefits, including a pension scheme, travel allowance, and professional training opportunities.

Join our team and take the opportunity to work with a world-leading company in the life sciences industry.

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