346859BR
Jun 08, 2022
Singapore

Job Description

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
• Enable Quality oversight to site operations/objectives.
• Participate/Complete performance appraisal, development and training. Self-develop and support teammates in building a high performance team with competency/proficiency.
• Support/Lead network governance meeting (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.
• Perform and be responsible in ensuring Batch record review and release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards
• Provide guidance/support in ensuring a smooth manufacturing operations, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards
• Provide support in ensuring success to new product launches or transfer and product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards (Eg: Product Transfer, Process Validation, Ongoing Process Verification, Annual Product Review Process etc)
• Provide guidance/support to be inspection ready and supporting internal Novartis or Health Authority audits/responses.
• Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• Experience:
- For Senior QA Operations Specialist: 5-8 Years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits or new product launches/tech transfer.
- For For QA Operations Expert: 8-10 Years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits or new product launches/tech transfer
• Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
• Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
• Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
• MS Office applications and other standard IT applications supporting Quality activities
• Collaboration; result-oriented

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!

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: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Singapore
Singapore
Quality
Full Time
Regular
No
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346859BR

Expert/Senior Specialist, QA Operations

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