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Operational Investigator

Life Sciences
QA
Bachelor, Master
Junior (0+)
Location
Ghent, East Flanders
Work type
Consultancy
Work model
Fulltime, Hybrid

Our client, a leading organization in the biopharmaceutical industry, is seeking an Operational Investigator to support their production facilities. This role focuses on leading cross-departmental investigations and risk assessments to ensure product quality and regulatory compliance within the project.

Responsibilities

  • Lead departmental investigations and risk assessments using root cause analysis tools in accordance with cGMP regulations.
  • Identify and implement CAPA actions and effectiveness checks linked to non-conformances.
  • Partner with cross-functional teams including Operations, QA, and Engineering to resolve issues and drive improvements.
  • Support internal and external audits through the preparation of necessary documentation.
  • Manage multiple tasks simultaneously to meet critical deadlines in a fast-paced environment.

Requirements

  • You have a Bachelor’s or Master’s degree in (Bio-)Engineering, Science, Pharmacy, or a related field.
  • You bring 1+ years of experience in handling and writing investigations within a cGMP or ATMP environment.
  • You possess experience in quality assurance including CAPA, deviation management, and risk assessment.
  • You have a proactive attitude with a high level of ownership, flexibility, and stress-resistance.
  • You're an excellent communicator with strong scientific writing skills.
  • You are fluent in English.

Nice to Haves

  • Prior experience in manufacturing or QA.
  • Experience with stakeholder management.

Offer

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
# 101370
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Candidates must be legally authorised to work in the EU and possess the required language skills for the job location.
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