Summary
The QC Technician performs Quality control analysis on finished product as well as on incoming materials according to cGMP rules and SOPs, performs routine GxP compliance/operational activities according to Novartis quality standards and makes analysis on batches and incoming materials according to cGMP rules and SOPs.
About The Role
In this role you will be required to work in rotating shifts, including night turns.
Major Accountabilities
Perform the analysis of batches following specific training;
Perform routine maintenance and cleaning, periodic microbiological verification of pharmaceutical areas quality control equipment and support external specialized personnel in carrying out extraordinary maintenance/qualification activities;
Perform incoming and outgoing verification activities of raw materials and materials;
Execute the calibration, verification, qualification and validation activities of the Quality Control processes and equipment;
Responsible for the oversight on manufacturing for QC sampling activities;
Raw material and finished product testing, environmental monitoring and sterility QC testing, and reporting of the QC results. Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures;
Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and change control management, including procedure and form revisions;
Participation in assigned qualification/validation activities, as necessary;
Prepare applicable documents, forms, and records such as analytical batch records and follow Good Documentation Practices;
Support internal and external audits and inspections, as required.
Minimum Requirements
Education: Chemical or biological degree is desirable;
Previous experience in radiopharmaceutical companies is desirable;
Fluent Italian, good knowledge of English.
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Benefits and rewards
Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Read our handbook (PDF 30 MB)
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