QA CSV Engineer
Antwerp
Life Sciences - QA
Bachelor, Master
Work experience: 5-7
Reference number: 90005
Explore an opportunity where your expertise will contribute to maintaining compliance in the highly regulated field of Computerized Systems Validation. In a challenging and dynamic environment, you will play a crucial role in supporting teams that ensure quality and adherence to regulatory standards.
As the ideal candidate, you are an experienced Analyst in Quality Assurance with a solid background in CSV and an understanding of both European and US regulations. Your strong problem-solving skills and ability to navigate complex situations will be essential in this position.
- You assure that all CSV related regulatory requirements are fulfilled throughout the complete life cycle of computerized systems.
- You review and approve CSV documents such as SOPs, user requirements, and Validation Plans to maintain compliance with regulations.
- You collaborate with IT and engineering teams, providing support and guidance for CSV activities.
- You address deviations during CSV activities and ensure thorough follow-up.
- You evaluate incidents related to Computerized Systems and propose corrective actions as necessary.
- You prepare periodic compliance reports on quality systems and assist in system audits and inspections.
- You stay current with international regulations regarding CSV and implement improvements as needed.
What are we looking for?
- You have at least 5 years of experience in Quality Assurance, particularly in Computer Software Validation.
- You are knowledgeable in cGMP guidelines (21CFR11, 21CFR210, 21CFR211) and GAMP principles.
- You possess skills in Quality auditing and software quality metrics.
- You are an excellent communicator and able to work independently or in a cross-functional team environment.
- You have a strong ability to multi-task and manage various projects simultaneously.
- You have a background in pharmaceuticals or have experience working under strict regulations.
- You are fluent in English and Dutch (spoken and written).
What do we 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.
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