Quality Operations Coordinator

• Manages Quality aspects & projects within area of responsibility. -Ensures and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems.
• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance -Support exception investigations -Review & approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Oversight of all Engineering, REFS activities Review and approval of Engineering & REFS records/documents Performing and documenting walkthroughs through the Engineering &REFS related areas Responsible of Qops Function training process (such as creation of the training plans etc)

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Collaborating across boundaries Functional Breadth QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones English Quality Control (QC) Testing Knowledge of GMP Knowledge of IT Applications & tools Quality Standards Quality Assurance

Division

Novartis Technical Operations

Business Unit

NTO QUALITY

Country

Turkey

Work Location

Kocaeli

Company/Legal Entity

Sandoz Grup

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

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