Regional Qualification senior specialist
Core
Verify parameters, operating conditions, and acceptance criteria; collect and validate data from suppliers to ensure data integrity and adherence to quality regulations for drug and vaccine qualification.
Role type
Senior data management specialist (qualification)
Builds
Qualification documentation and data packages for R&D and Manufacturing facilities
Domain
Life sciences / Pharmaceutical manufacturing / Quality assurance
Deliverable
client delivery
Required skills
Data transcription and verification, Data integrity management, Quality system compliance, Project documentation, Meeting scheduling, Analytical thinking
Preferred skills
Engineering, pharmacy, chemistry, or biology background, Multilingual communication (French, German, Italian, Spanish, Russian, Hungarian)
Technologies
Veeva, Kneat, Microsoft Word, Excel, PowerPoint
Responsibilities
Verify parameters and acceptance criteria per SOP, Collect electronically stored data from suppliers, Ensure data integrity and adherence to quality rules, Prepare data for analysis by qualification experts, Schedule formal consolidated review and approval meetings
Seniority
Senior, hands-on IC
