339472BR
Apr 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 providing front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to allow continuously improving in quality, productivity efficiency.

Key Responsibilities
• Responsible for effective and timely closure of minor and major manufacturing investigations involving cross-functional teams ensuring robust CAPAs are implemented.
• Provide support to manufacturing operations in terms of subject matter expertise in areas of deviations and CAPA.
• Facilitate investigations for major deviations as needed.
• Responsible for effective and timely closures of change records or quality event records related to manufacturing operations.
• Participate in and lead continuous improvement initiatives to enhance deviation/CAPA management process for the site. Drive quality culture in areas of deviation and CAPA management across manufacturing operations.
• Write, review, facilitate and approve Standard Operating Procedures (SOPs), Change Controls, Quality Risk Assessments (QRAs), Quality Plans, Trainings as needed.
• Support site Quality and Compliance programs as needed.

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 in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent
• Minimum 5 years and above experience in investigations for deviations
• Minimum 2 year experience in GMP manufacturing process support role
• Good scientific and technical (automation) understanding
• Change management, adaptability, ability to work under pressure
• Good understanding or capacity to quickly understand production processes

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 Contract Manufacturing
Singapore
Singapore
Technical Operations
Full Time
Regular
No
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339472BR

Senior Specialist - Mfg Investigations

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