As&t Facilitator

The AS&T Facilitator ensures the appropriateness of Quality Control processes for product manufactured in the facility, and that batches quality control and QC equipment validation/qualification, QC method are executed and fully compliant to cGMPs regulation, corporate and national guidelines.
The person is responsible for developing, implementing and managing the site qualifications and requalification of existing analytical equipment and cycles as well any new equipment to meet cGMP and quality requirements.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan.
- Coordination of projects related to quality control implementations.
- Ensure that all methods used in QC analysis are validated/verified according to SOPs, MA and cGMPs and Pharmacopoeias.
- Assure the adequacy of the SOPs of Quality Control department.
- Involvement in APR redaction and stability programs redaction.
- .Support the QC manager in verifying the data integrity of the QC software.
- Ensure, in collaboration with QC Manager, that OOS, OOE, OOT, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs.
- Participate in transfers and launches by aligning on the product validation approach, being the contact point for TRD and TechOps.
- Involvement in QC qualification and requalification program, method development, QC technologic improvement.
- Partner with Engineering, IT, QC, MS&T, AS&T to define the interfaces to equipment, utilities and system qualification, analytical method validation.
- Be the Deputy of QC Manager in reviewing and approving the execution of the analytical activities for the batch release if needed 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 in Pharmacy, Chemistry or Biology.
- +2 years of experience in analytical laboratory, method development, qualification of HPLC, GC, TLC,ecc
- 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.
- Fluent in 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