QA Compliance Expert
Vor 2 Tagen
**QA Compliance Expert, Novartis, Stein, Switzerland**
150 Novartis Stein Small Molecules is one of the most important sites for innovative, high quality and difficult to produce medicines for solid dosage forms. We produce, pack and control capsules and tablets for patients in more than 150 countries.
This role is limited for 24 months.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- 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.)
- SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
**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**:
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- Experience in pharmaceutical quality control, quality assurance or production
- Business-level/ fluent English; fluent in local language (oral and written)
- Ability to work in an open, interdisciplinary and collaborative environment
- Accurate and independent working style
**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
**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
**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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