- Ludwigshafen, Rhineland-Palatinate, Germany
- Full-time · Senior
- 5+ years
Provide quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization.
Responsibilities
- Provide interpretation, guidance, and training for business partners regarding software qualifications / validation and related regulatory regulations / guidelines, including data integrity and AbbVie policies / procedures.
- Support Business System Owner and Business SME with their IT software projects and goals.
- Advise project teams, Business System Owners, and Business SMEs on risk-based CSV / CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and system changes.
- Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
- Provide technical guidance, coaching, and training to RDQA colleagues and business partners on CSV / CSA, data integrity, validation, and quality system expectations.
Requirements
- Graduated Engineer (FH) or bachelor's degree in natural sciences
- Nice to have: AI/ML-enabled technologies
- Nice to have: advanced analytics platforms
- Nice to have: automation solutions
- Nice to have: digital quality systems