Expert Assurance Qualité Qualification (F/H/X)
Core
Ensure computerized system qualification activities comply with GMP and site Quality Assurance rules for AbbVie's pharmaceutical operations.
Role type
Senior IC Quality Assurance Expert (Computerized System Qualification)
Builds
Qualified computerized systems for pharmaceutical production and control
Domain
Pharmaceutical industry, Quality Assurance, Computerized System Validation
Required skills
GMP compliance, deviation management, CAPA management, audit preparation, regulatory inspection support, change control, qualification strategy review, data verification, document approval
Preferred skills
Technical and organizational solutions for qualification compliance
Technologies
GMP, BPF, CAPA, deviation tracking, audit tools
Responsibilities
Organize and execute QA verification of raw data and GMP document reviews related to qualification activities; Decide and provide recommendations in accordance with GMP requirements; Pilot deviations, investigations, CAPA, and changes related to qualification follow-up; Review and approve computerized system qualification strategies and tracking; Maintain the qualified status of computerized systems; Actively participate in preparing, conducting, and following up on group audits, regulatory inspections, and self-inspections in the qualification domain; Propose technical and organizational solutions to ensure qualification compliance