QA CSV Engineer
Antwerp
Life Sciences - QA
Master
Work experience: 0-3
Reference number: 93427
Join a cutting-edge team dedicated to ensuring the highest standards in computerized systems validation (CSV) within the regulatory framework. This is an exceptional opportunity for a motivated professional to make a significant impact in the pharmaceutical industry.
As an ideal candidate, you are a skilled QA CSV Engineer prepared to tackle complex challenges in a dynamic environment. You thrive in cross-functional teams and possess a keen understanding of regulatory requirements.
- You assure that all CSV related regulatory requirements are fulfilled throughout the complete life cycle of computerized systems.
- You review trends within the CSV area and initiate actions for improvements.
- You act as a mediator among various groups regarding CSV matters.
- You maintain the Validation Master Plans and ensure timely execution of validation activities.
- You review and approve CSV documents to ensure compliance with regulations and organizational standards.
- You participate in the introduction of new systems and processes, providing valuable advice on CSV-related activities.
- You prepare for audits and inspections, acting as the spokesperson for CSV during these evaluations.
What are we looking for?
- You have a university degree or similar qualification.
- You possess at least 3 years of experience in a similar role.
- You have expertise in cGMPs, specifically 21CFR11, 21CFR210, and related guidelines.
- You bring strong problem-solving skills to address challenging situations.
- You are an excellent communicator, capable of conveying technical information at all levels of the organization.
- You are proficient in English and Dutch.
- You have specific knowledge of Quality Management Systems and IT systems used in pharmaceutical manufacturing.
- You hold familiarity with Deviation and Change Management Systems.
- You have experience with Test Tools like qTest and KNEAT.
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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