Data Integrity Specialist QA-CSV
Life Sciences
Validation and Qualification
- Location
- Beerse, Antwerp
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
Our client, a leading pharmaceutical organization, is looking for a Data Integrity Specialist QA-CSV to support their supply chain systems. This role involves managing quality and compliance for diverse systems within a regulated environment, ensuring data integrity across various operational activities.
Responsibilities
- Assess systems and equipment to identify data integrity risks and vulnerabilities within a regulated environment.
- Define and implement remediation activities and data integrity plans for local systems.
- Lead data flow mapping and risk assessment sessions for site-specific equipment.
- Provide technical guidance and support to internal stakeholders regarding data integrity standards.
- Serve as a subject matter expert for data integrity during internal audits and regulatory inspections.
- Collaborate with engineering and IT teams to maintain compliance during the introduction of new systems and processes.
- Maintain current knowledge of international laws and guidelines related to computerized system validation.
Requirements
- You have a Master’s degree in a scientific field or equivalent professional experience.
- You bring 3+ years of experience in the pharmaceutical industry.
- You have experience in Computerized System Validation and Data Integrity remediation.
- You possess knowledge of compliance frameworks including cGMP, 21 CFR Part 11, Eudralex 4, and GAMP.
- You have a strong quality mindset with the ability to make risk-based decisions.
- You are fluent in English and Dutch.
Nice to Haves
- Experience leading sessions with data integrity representatives across multiple sites.
- Familiarity with platform-based data flow mapping and risk assessments.
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.
Thank you for your interest. Unfortunately, job applications are not available in your region. To ensure a high-quality match for our clients and streamline the application process, we have certain regional limitations in place. We value all potential candidates and encourage you to explore opportunities with us in the future.
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