Leader C&Q F/H
Core
Lead C&Q (Computerized & Qualification) strategies for pre-project studies in the pharmaceutical industry, ensuring compliance, timelines, and costs.
Role type
Senior C&Q Project Leader
Builds
Validation protocols, risk analyses, and qualification plans for pharmaceutical industrial projects
Domain
Pharmaceutical engineering and industrial processes
Required skills
C&Q strategy development, regulatory compliance, risk analysis, document management, project planning, non-conformance management, audit participation
Preferred skills
Process engineering knowledge, team collaboration, communication
Technologies
URS, SAT/IQ/OQ/QP protocols, risk analysis tools
Responsibilities
Develop and pilot C&Q strategies, ensure compliance with deadlines and costs, write/approve C&Q documents, manage project schedules, handle non-conformities, ensure action traceability, participate in audits
Seniority
Senior, hands-on IC