04 ago - Italia
Dormont Manufacturing
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.
Benefits and rewards
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