Qc Supervisor - Colleretto Giacosa, Italia - Novartis
Descrizione
390929BRQC Supervisor:
Italy
AAA Statement
Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.
Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
About the role
The QC Supervisor supports the QC Manager to ensure that Quality Control processes for materials acceptance, batches quality control and QC equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Raw materials, packaging materials, semi-finished products acceptance according to specifications.
- Be the Deputy of QC Manager in managing, coordinating and approving the execution of the analytical activities for the batch release when QC Manager is not on site.
- Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan.
- Ensure that all methods used in QC analysis are validated according to SOPs, MA and cGMPs.
- Support the QC Manager to assure the adequacy of the SOPs of Quality Control department.
- Support the QC Manager to perform the APR achievement according to the calendar, the audit trail review of the quality control equipment software and in verifying the data integrity of the QC software.
- Ensure that all QC materials are properly and safely stored, identified, labelled recorded and monitored according to SOPs and specifications.
- Ensure that the stock of materials, reagents, standards is properly available and ordered.
- Ensure, in collaboration with QC Manager, that out of specifications, out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs.
- Manage the presence, shifts and performances of the QC Technicians when QC Manager is not on site.
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements
What you'll bring to the role:
- Degree in scientific disciplines. Degree in Chemistry preferred.
- At least 2 years' experience within the QC department of a pharmaceutical company.
- Good knowledge of quality control and production in a GMP environment.
- Good organizational skills (time management, risk management) including attention to detail and multitasking skills
- Fluent in Italian and good knowledge of English.
Division
Oncology
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Work Location
Colleretto Giacosa
Company/Legal Entity
AAA Italy Srl.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
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