Qc Supervisor

hace 2 semanas


Zaragoza, España Novartis A tiempo completo

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, to perform the APR achievement according to the calendar, to perform the audit trail review of the quality control equipment software and verify the data integrity of the QC software.
- Maintain, review and approve the records of the QC activities.
- 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.
- Collaborate with QC Manager for the redaction of the stability programs and the annual product review and to ensure the initial and periodic training of QC analysts.
- Manage the presence, shifts and performances of the QC Technicians when QC Manager is not on site.
- Collaborate with QC Manager for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier).

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Scientific Degree (Chemistry degree preferred).
- +2 years of experience in QC department.
- Good organizational skills (time management, risk management) including attention to detail and multitasking skills.
- Open and clear collaboration and communication to make sure the daily operation runs smoothly
- Shows the appropriate sense of urgency around given tasks
- Good knowledge of English.

Work location: Zaragoza.

**Why Advanced Accelerator Applications?**
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis

**Imagine what you could do at Novartis**

**Division**

Oncology

**Business Unit**

ADVANCED ACCELERATOR APPLICATIONS

**Country**

Spain

**Work Location**

Zaragoza

**Company/Legal Entity**

AAA Ibérica S.L.U.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No