Process Expert

vor 1 Monat

Stein, Schweiz Novartis Vollzeit

80million This is the number of sterile products that are processed in our workplace per year. As part of the production team, you will play a key role in manufacturing and ensuring the highest product quality for millions of patients in more than 150 countries around the world. For the Process Unit (PU) Galenic we are looking for a motivated and committed process expert in aseptic manufacturing.
- A Process Expert provides front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to allow continuously improving in quality, productivity efficiency.**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Provide front line expert support for all process-specific issues to production
- Act as Subject Matter Expert (SME) for the product and process
- Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules
- Ensure timely treatment of deviations, complaints, OOE, OOS, and the implementation of effective CAPAs within agreed timelines
- Lead thorough Root Cause Investigation process using investigation tools and methodology
- Contribute in continuous improvements projects in collaboration with MS&T experts and in compliance with cGMPs, SOPs, applicable guidelines
- Ensure the management of the various projects entrusted to him: coordinate the stages defined in the projects and ensuring timely completion and compliance with cGMPs and HSE
- Promote and improve the Quality culture in collaboration with Quality Assurance.

**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**:

- Minimum 2 year experience in GMP manufacturing process support role
- Min. 8 year experience in the field of expertise for lower Education levels
- University degree in Science is desirable, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience
- Advanced English and proficient in site local language
- Good scientific and technical (automation) understanding
- Team player with strong team spirit
- Change management skills, adaptability, ability to work under pressure
- Good understanding or capacity to quickly understand production processes
- Quality and compliance skills
- Good understanding of regulatory requirements across multiple health authorities
- Good working knowledge/understanding of manufacturing execution systems (MES, SAP, or relevant...)

**Why consider Novartis?**

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- 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 Novartis

**Division**
- Novartis Technical Operations

**Business Unit**
- LARGE MOLECULES

**Country**
- Switzerland

**Work Location**
- Stein (Säckingen)

**Company/Legal Entity**
- Novartis Pharma AG

**Functional Area**
- Technical Operations

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes

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