344366BR
May 05, 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.
This role is responsible for operational leadership of a defined area / laboratory within the site’s AS&T unit. Ensure compliance with all cGxP, regulatory and HSE aspects as well as responsible for people leadership within are of responsibility.

Key Responsibilities
• Establish and maintain the AS&T, QC Compliance and QC Scheduling teams in full cGMP-compliance.
• Ensure successful and on time Method transfers and Method Validations / Verifications.
• Ensure AST team handle major deviations and investigations and provide technical expertise to the QC labs
• Ensure planning and scheduling is in place for QC operations. Ensure all inspection commitments, CAPA’s, Deviations, OOS/OOE and other quality records are closed on time.
• Ensure all analytical records are reviewed and CofA (Certificate of Analysis) is generated per schedule.
• Creates, implements, and supports assay trending systems for monitoring method performance.
• Optimize test procedures to improve efficiency whenever possible and provides technical assistance to various departments and stakeholders.
• Trains QA/QC analysts on new methods and instrumentation

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:
o PhD: 8+ years related experience with 3+ years in management, or
o MS or equivalent: 10+ years’ experience with 5+ years in management, or
o BS: 12+ years related experience with 5+ years in management
• Related experience should be in GMP-regulated industries in Quality Control
• Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems
• Must have an understanding of pharmaceutical industry trends and practices
• Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Why consider Novartis?
769 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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344366BR

QC Team Leader - AS&T

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