Summary
The QC Technician performs quality control analysis on finished products and incoming materials according to cGMP and SOPs. They carry out routine GxP compliance and operational activities following Novartis quality standards, analyzing batches and materials in accordance with cGMP rules and SOPs.
About The Role
This role requires working in rotating shifts, including night shifts.
Major Accountabilities
- Perform analysis of batches following specific training.
- Perform routine maintenance, cleaning, and microbiological verification of pharmaceutical areas and QC equipment; support external personnel in maintenance and qualification activities.
- Verify incoming and outgoing raw materials and materials.
- Execute calibration, verification, qualification, and validation activities for QC processes and equipment.
- Oversee manufacturing for QC sampling activities.
- Test raw materials and finished products, conduct environmental monitoring and sterility QC testing, report results, and manage non-conformances and deviations per AAA procedures.
- Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up, and change control management, including document revisions.
- Participate in qualification and validation activities as necessary.
- Prepare documents, forms, and records such as analytical batch records, following good documentation practices.
- Support internal and external audits and inspections as required.
Minimum Requirements
- Education: A degree in chemistry or biology is desirable.
- Previous experience in radiopharmaceutical companies is desirable.
- Fluent in Spanish with good knowledge of English.