Senior QA Specialist
Core
Leading and supporting Quality Assurance activities for technology transfer projects, ensuring effective knowledge transfer, risk management, and implementation of quality requirements for new manufacturing technologies and digital solutions.
Role type
Senior QA Specialist (Technology Transfer & Digitalization)
Builds
New manufacturing technologies, equipment, computerized systems, and digital solutions for pharmaceutical production.
Domain
Pharmaceutical manufacturing / Quality Assurance / Technology Transfer
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project leadership, risk management, GMP compliance, computerized system validation, data integrity, regulatory knowledge (21 CFR Part 11, Annex 11, GxP), MES implementation, process simplification, quality strategy development, KPI monitoring
Preferred skills
Digital transformation experience, continuous improvement, automation, cross-functional collaboration
Technologies
Manufacturing Execution Systems (MES), electronic batch records, automation platforms, data historians, analytics tools, system integrations
Responsibilities
Leading QA activities for technology transfer projects, providing oversight for new manufacturing technologies and digital solutions, partnering with cross-functional stakeholders, facilitating project governance and risk assessments, driving adoption of data-driven quality approaches, supporting implementation of MES and automation solutions, developing quality strategies and governance frameworks, monitoring project progress and KPIs
Seniority
Senior, hands-on IC
