QA Operations Specialist

6 days ago

Singapore Novartis Full time

More than 380 That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.**Key Responsibilities**
- Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance and Support exception investigations
- Support day to day operations of QC, Analytical method and validation
- Determine and approve QA requirements for quality events, deviations, OOS investigations, review
- Perform Change control evaluations & Annual Product Quality Review
- Collaborates with different functions during investigation or daily activities
- Review documents with focus on QC related areas including reports, SOPs, change controls, compendia updates, testing monographs, DS CoA, stability protocols and reports in compliance with Regulatory and Novartis requirements
- Successfully support continuous improvement projects and carries out batch release in compliance with registration

**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**
- Minimum 6-8 years' experience in pharmaceutical GMP-regulated industries (Biotech preferred) in QA for QC / Quality Assurance
- Collaborating across boundaries Functional Breadth QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones
- Strong foundation and knowledge in investigative root cause analysis
- Able to collaborate across all functions in the organization
- Good understanding of QC analytics, OOS management and raw material management.
- Experience in reviewing technical reports

**Why consider 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 at Novartis**

**Division**
- Novartis Technical Operations

**Business Unit**
- NTO QUALITY

**Country**
- Singapore

**Work Location**
- Singapore

**Company/Legal Entity**
- NOV SINGAPORE PHARMA MANUFG

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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