Aseptic Process Lead

769 million. That's how many lives our products touched in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
- This is a great opportunity for a person with communicative skills, responsible, with initiative, proactive and with a great capacity for teamwork.
- As Aseptic Process Lead you will be responsible for maintaining, managing, support and continuously improving the aseptic process, in collaboration with all site departments for the operational area assigned, and back up for the other one, and following Risk Assessment Principles and Continuous Improvement Concept.**Your responsibilities include, but not limited to**:

- Provide support and improve the aseptic techniques, operations and processes.
- Review and approve validation documents related to aseptic operations and processes.
- Give guidance for the investigations related to OOLs or aseptic processes, especially those impacting the release decision.
- Support Aseptic Process Validation (Media Fill) and Air Flow Pattern Validation (Smoke Studies) through training, oversight, and report approvals.
- Environmental Monitoring Program Management and Aseptic Improvement following Risk Based Approach
- Lead the implementation of new standards or regulations related to aseptics and contamination control.
- Support audits and regulatory inspections during the execution and preparation the answers to the possible observations or finding detected.
- SME role for the topics assigned related to aseptics, especially for the Continuous Improvement projects related to critical areas within the Plant (Utilities, Steam, Water, PNV, Biofilm Risk, etc)

**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**:
**Must have**:
- University degree in life sciences, preferably in biologics, pharmacy, or equivalent
- At least 5 years’ experience in the pharmaceutical industry focus on sterile business, preferably in an FDA-regulated environment (Sterile, Solids, API and Drug Products) and in QA Operations & Compliance Quality Assurance.
- Strong knowledge of cGMP regulations in USA, EU (Self Inspections, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
- Fluent Spanish and English (other languages are a plus)
- Teamwork and good communication and organization skills
- Decision-making skills

**Nice to have**:
- Previous experience in Quality Department including but not limited to Quality Assurance, Compliance or Quality Control.
- Project Management (Managing of cross-functional projects)
- Experience in cooperation with partners in other Novartis sites and good interaction with global organization.

**You’ll receive**:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.**Why Sandoz**
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and ground-breaking 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 Sandoz**Division**
- Novartis Technical Operations

**Business Unit**
- NTO QUALITY

**Country**
- Spain

**Work Location**
- Barcelona Palafolls

**Company/Legal Entity**
- Sandoz Industrial Product

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No