QA CSV Engineer

Our client, a prominent pharmaceutical organization, is seeking a professional to ensure the quality and compliance of computerized systems. This role involves managing the lifecycle of various systems within a complex supply chain environment.

• Assure that all CSV regulatory requirements are fulfilled during the complete life cycle of computerized systems from concept to retirement.
• Act as a process owner for the periodic review of computerized systems to ensure timely execution.
• Review and approve validation documentation including SOPs, URS, risk analysis, and test scripts.
• Provide support for audits and inspections by regulatory agencies and internal compliance teams.
• Offer advice on cGMP aspects in new projects as part of multi-functional teams.
• Maintain up-to-date knowledge of international laws and evolutions related to CSV to improve internal processes.
• Collaborate with engineering and IT teams for the introduction of new systems and processes.

• Master scientific degree.
• You bring 3+ years of experience in CSV and quality assurance within the life sciences sector.
• You possess knowledge of regulatory standards such as 21 CFR Part 11, Eudralex Volume 4, and GAMP.
• You have experience with Data Integrity remediation and risk-based quality decision-making.
• You're an organized and communicative professional with a strong quality mindset and factual approach.
• You are fluent in English and Dutch.

Nice to Haves

• Experience working with various IT systems and periodic control processes.
• Direct experience with Data Integrity Guidelines.

• 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.