Computerized System Assurance Expert
il y a 3 semaines
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Computerized System Assurance Expert - Kontich - Crosspoint Solutions, DuffelClient:Crosspoint Solutions
Location:Duffel, Belgium
Job Category:Other
EU work permit required:Yes
Job Reference:2e215c5e2f5f
Job Views:5
Posted:15.02.2025
Expiry Date:01.04.2025
Job Description:Are you a consultant at heart? Are you ready to help shape a company with your insights and experience?
Do you have 3+ years of experience in CSV and strong knowledge of CSA? Are you eager to take the next step in your career?
We’re looking for someone who knows the ins and outs of compliance and is ready to help our customers achieve both regulatory excellence and operational efficiency. If you have a keen interest in new methodologies like Agile, a curiosity for innovation, and a desire to keep learning, this could be your next challenge. Join our team and grow your career in the evolving pharmaceutical and biotech industry
Background- You have a minimum of 3 years of experience in a pharmaceutical environment.
- You have in-depth knowledge of GxP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Annex 11, 21 CFR Part 11).
- You have experience with Computerized System Assurance, experience with Agile methodologies is a plus.
- You have knowledge of Quality Systems.
- You have experience in Data Integrity and Risk management.
- You are fluent in Dutch and English; French is a plus.
- You have a high level of autonomy and proactivity.
- You have good interpersonal skills resulting in an effective team player.
- You are client-oriented with excellent stakeholder management skills.
- You have a strong quality mindset.
- The opportunity to join our GGC team, a diverse and dynamic team within a growing company where you can take up initiatives and responsibilities and work on projects for top international and Belgian companies within the life science industry.
- A GGC working environment, which stands for collegiality, open communication, and defining your own career path within a flexible and flat structure.
- Training, coaching, and knowledge sharing by colleagues and sister companies based on your needs.
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