Novartis
Pharmaceutical
SeniorQualityAssuranceOperationsSpecialist
“Senior Quality Assurance Operations Specialist at Novartis. Skills: Quality Assurance, GMP Compliance. Review and approval of batch manufacturing records. Review and assessment of analytical results”
What You'll Achieve.
Timely and compliant batch release
Industry & Context.
Problem Solving Skills
Fixed term of two years
What They're Looking For.
Must Have
Solid experience in pharmaceutical or GMP-regulated environment, Knowledge of GMP requirements, Fluent in German, Basic English
Nice to Have
Experience in Quality Assurance or quality control
What You'll Do.
Review and approval of batch manufacturing records
Review and assessment of analytical results
Control and verification of batch documentation
Support audits and inspections
Support investigations related to deviations
Support OOS/OOE investigations
Support complaint investigations
Support CAPA management activities
Support changes to processes
Support changes to documentation
Support changes to quality requirements
Preparation of certificates
Preparation of reports
Preparation of quality-related lists
Review of certificates
Review of quality-related lists
Communication with internal departments
Coordination with internal departments
Communication with external partners
Coordination with external partners
Execution of tasks in a timely manner
Execution of tasks in an efficient manner
Execution of tasks in a GMP-compliant manner
How You'll Work.
Team & Collaboration
Internal departments; External partners
Communication Scope
Communication skills
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