Quality Assurance Manager

hace 1 día


Bogotá, Bogotá D.E., Colombia Novartis Farmacéutica A tiempo completo

About the Role
As a Quality Operations Specialist at Novartis Farmacéutica, you will be responsible for ensuring compliance with cGxP regulations in production and testing activities. Your key performance indicators will include managing quality aspects and projects within your area of responsibility.

Main Responsibilities
- Supervise all production and testing activities to ensure compliance with cGxP regulations.
- Investigate exceptions and support OpEx improvement projects.
- Review and approve production records, quality control, AS, and T. Review MBR.
- Execute batch release in compliance with registration.
- Notify technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.

Required Skills and Qualifications
- Work Experience in QC/QA in pharmaceutical/biotechnology industry with environmental control and clean room experience.
- Functional breadth and 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, and language English.



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