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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