Novartis
QualityControlTechnician
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Control Technician at Novartis. Skills: Quality control analysis, cGMP r and SOPs, GxP Compliance/ Operational activities, Quality Control processes, QC sampling activities, Raw Material and Finished Product testing, Environmental Monitoring, Sterility QC testing, deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, Change Control management, procedure and form revisions, analytical batch records, internal and external Audits and Inspections. Perform Q”
What You'll Achieve.
reporting of the QC results; Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures
Industry & Context.
deviation investigations; OOS/OOT/OOE investigations
work in rotating shifts, including night turns
What They're Looking For.
Must Have
cGMP r and SOPs, Novartis Quality Standards, cGMP rules and SOPs, rotating shifts, including night turns
Nice to Have
Previous experience in radiopharmaceutical companies, Fluent Italian, good knowledge of English
What You'll Do.
Perform Quality control analysis on finished Product as well as in incoming materials according to cGMP r and SOPs
performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards
makes analysis on batches and incoming materials according to cGMP rules and SOPs
Perform the analysis of batches following specific
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
Perform incoming and outgoing verification activities of raw materials and
Execute the calibration
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
Prepares applicable documents
and records such as analytical batch records and follows Good Documentation Practices
Support internal and external Audits and Inspections
How You'll Work.
Team & Collaboration
support external specialized personnel in carrying out extraordinary maintenance/qualification; Support deviation investigations; Support internal and external Audits and Inspections, as required
Communication Scope
Fluent Italian; good knowledge of English
Process & Methodology
CAPA follow up and implementation, Change Control management
Full Job Description
**Band** Level 2 **Job Description Summary** The QC Technician performs Quality control analysis on finished Product as well as in incoming materials according to cGMP r 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. **Job Description** ** _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. * Prepares applicable documents, forms, and records such as analytical batch records and follows 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. **Why Novartis?*
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