QA Compliance Expert

vor 3 Wochen

Stein, Schweiz Novartis Vollzeit

766 million That's how many patients' lives were touched by our products in 2021. At Novartis, we are reimagining medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. How can we continue to advance our science to help even more patients in need? We believe the answers are found when curious, courageous, and collaborative people are empowered to ask new questions, make bolder decisions, and take smarter risks.
- In our NTO division we are looking for an experienced QA Compliance Expert who will manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). Our colleague will also perform preparation and management of external and corporate audits and Health Authority inspections. Join our amazing team in NTO and help reimagine medicine
- Major accountabilities:
- Planning and supporting PQR/APQR activities.
- Support site qualification and validation activities (planning, advising, review).
- Implementation of Quality Systems (incl. documentation management).
- Supplier management activities (agreements, oversight, audit).
- Preparation/support & coordination of CAPA/follow-up -Audit and inspection preparation and support.- Change control review/approval.
- Ensure local DI & eCompliance oversight (training, inspections, plan, risk ID etc.).
- Ensure process quality assurance acc. to regulations.
- QP declaration review and approval.- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

This is a temporary position, limited to 24 months.

**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**
- University or academic degree in Chemistry, Biology, Pharmacy or equivalent,
- Post graduate diploma in business administration or equivalent,
- German and English fluency, both spoken and written,
- Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles / Biotechnology,
- Profound knowledge of cGMPs,
- Team player, as well as capable of working independantly, when needed.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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**
- NTO QUALITY

**Country**
- Switzerland

**Work Location**
- Stein (Säckingen)

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

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Temporary

**Shift Work**
- No

**Early Talent**
- No

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