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QA Specialist - C&Q

Life Sciences
QA
Location
Beerse, Antwerp
Work type
Consultancy
Work model
Fulltime, Hybrid

Our client, a leading pharmaceutical organization, is seeking a QA Specialist - C&Q to join their team. This role focuses on ensuring compliance across the system lifecycle by overseeing qualification activities and maintaining high quality standards.

Responsibilities

  • Review and approve qualification deliverables such as URS, risk assessments, and DQ/IQ/OQ/PQ protocols and reports.
  • Oversee procedures related to the qualification, calibration, maintenance, and lifecycle management of systems.
  • Assess and investigate deviations related to system qualification and use, ensuring effective CAPA implementation.
  • Stay updated on international regulations and industry practices to continuously improve qualification processes.
  • Support regulatory inspections and internal audits as a subject matter expert for qualification-related topics.
  • Collaborate with cross-functional stakeholders to ensure project timelines and quality objectives are met.

Requirements

  • You have 3+ years of experience in QA or C&Q within a regulated environment.
  • You bring expertise in qualification deliverables including DQ, IQ, OQ, and PQ.
  • You possess a strong knowledge of URS and risk assessment methodologies.
  • You're an excellent communicator with the ability to challenge stakeholders constructively.
  • You possess a strong quality and compliance mindset.

Nice to Haves

  • Experience with CAPA and deviation management systems.
  • Knowledge of international industry practices for system qualification.

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.
# 103430
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