QA Compliance Expert

vor 2 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 plan and execute assigned GMP QA Compliance tasks related to the support of sterile manufacturing, such as: supporting qualification/validation activities related to routine manufacturing and launching projects, review and approval of GMP relevant documentation, Change Control, Deviation handling and representation of QA Compliance Qualification & Validation in dedicated project(s). Join our amazing team in NTO and help reimagine medicine
- Major accountabilities:
- Leading all QA Compliance Qualification & Validation activities within Stein Steriles, PU Packag-ing (e.g. in project meetings for launch product or meetings related to commercial manufactur-ing),
- Review and approval of Equipment, Facility and Utilities Qualification Protocols and Reports in-cluding associated Risk Assessments and Deviations (on paper and/or in COMOS),
- Review and approval of Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers, Computer System Validations and Filter Validations) including associated Risk Assessments and Deviations,
- Review and approval of other documents within the scope of the department (e.g. Ongoing Pro-cess Verification, Shipping Verifications, Leachable/Extractable reports, etc.),
- Perform Quality risk assessments in case of critical/major deviations and initiate management escalation process if applicable,
- Review and approval of SOPs and FRMs within the scope of the department as well as definition and maintenance of relevant procedures,
- Perform & Support of GMP and other relevant trainings within the organization. Onboard/train/develop team members,
- Support inspections and audits (e.g. Health Authority and Customer inspections).

**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.

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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**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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