Quality Operations Specialist
hace 3 semanas
Quality Operations Specialist - Batch Release Job ID: REQ-10038282 Date: Feb 20, 2025 Location: Colombia Summary About the Role Major Accountabilities: Supervise all production and testing activities, ensuring compliance with cGxP, including data integrity and electronic compliance.
Support in investigating exceptions.
Review and approve production records, quality control, AS, and T. Review of MBR.
Support in OpEx improvement projects.
Execute batch release in compliance with registration.
Notify technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Distribute marketing samples (when applicable).
Key Performance Indicators: Manage quality aspects and projects within the area of responsibility.
Ensure and support overall compliance with GxP and Novartis quality management systems.
Work Experience QC/QA in pharmaceutical/biotechnology industry with environmental control and clean room experience.
Functional breadth.
International collaboration.
Skills Technological Intelligence.
QA (Quality Assurance).
GMP Procedures.
Quality Standards.
Quality Control Testing (QC).
Dealing with ambiguity.
Self-awareness.
Continuous learning.
Technological experience.
Language English Why Novartis: Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives.
Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you?
Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.
Company / Legal Entity: CO01 (FCRS = CO001) Novartis de Colombia S.A #J-18808-Ljbffr
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