Lonza
Pharmaceutical
QualityEngineering,QASpecialist,ProjectDelivery(CQ&CSV)
“Quality Engineering, QA Specialist, Project Delivery (CQ & CSV) at Lonza. Skills: Qualification, Validation, Compliance, Project Delivery. Ensure qualification and validation compliance. Review and approve protocols and reports”
What You'll Achieve.
Safeguard Lonza’s adherence to global quality standards; Safeguard adherence to regulatory expectations; Drive consistency across CAPEX projects; Maintain compliance consistency; Support inspection readiness; Support audit activities
Industry & Context.
analytical and problem-solving skills; proactive approach to compliance and risk management
What They're Looking For.
Must Have
Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or Biological Sciences, background in qualification, validation, and compliance within a regulated pharmaceutical environment, Experience with GMP regulations and global quality standards, Solid understanding of commissioning, qualification, and validation processes for equipment and computerized systems, analytical and problem-solving skills with a proactive approach to compliance and risk management, Excellent communication and stakeholder management skills, with the ability to represent QA in cross-functional teams, Business fluent in English
What You'll Do.
Ensure qualification and validation compliance
Review and approve protocols and reports
Provide guidance on cGMP
Assess impact of regulations
Act as Global QA voice
Support Project Quality Reviews
Contribute to internal audits
Review and approve documentation
Uphold data integrity principles
Translate regulatory trends
Harmonize commissioning standards
Harmonize qualification standards
How You'll Work.
Team & Collaboration
Represent Global QA in cross-functional teams; Work closely with Global Quality Engineering Project Delivery; Work closely with internal teams
Communication Scope
Excellent communication; Stakeholder management
Process & Methodology
Project Delivery, CAPEX projects
Applying for this Quality Engineering, QA Specialist, Project Delivery (CQ & CSV) role?
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