Senior/Expert, QA support function

Oct 19, 2021

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 position will be responsible as QA Ops Specialist provides QA oversight for QC, warehouse, raw materials and utilities ensuring product quality.

Key Responsibilities
• Guide and advise on QA Operations oversight of all support functions to support manufacturing operations including incoming material management (Raw Materials, Consumables, Supply chain systems), QA for the site QC function (Raw Material testing, Microbiology EM and product, In-Process Control, Bioanalytical testing and any other outsourced testing), Plant infrastructure and utilities, including maintenance and monitoring
• Review and approve documents required for establishing analytical methods on site, including and not limited to method transfer plan, protocols, and reports and making sure its comply with cGMP and applicable regulations and Novartis Quality Manual
• Determine QA requirements for quality events, deviations, OOS investigations, review and approve quality events, deviations, OOS investigations.
• Lead and resolve issues by collaborating with stakeholders from within and across various functions to meet health, safety, training or quality requirements including quality events, deviations, OOS investigations in the QC laboratories, warehouse and utilities and raw materials.
• Review and approve 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.
• Participate and contribute as a representative of the operational QA in project teams (e.g. Deviation Review Board, Change Review Board, Product Release Board, Material Management Board etc.)
• Establish applicable Novartis Policies and Systems for support functions to ensure Quality processes are current, maintained and followed. Act as SME (Subject Matter Expert) to train and guide site personnel in designated quality areas including investigations.
• Provide QA oversight for SAP-QM system and any other duties assigned by the manager

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

• Bachelor of Science in Natural Sciences (Biotech preferred) or related
• Minimum 6-10 years' experience in pharmaceutical GMP-regulated industries (Biotech preferred) in QA for QC / Quality Assurance / Compliance
• Experience with health authority inspections from major Health Authorities, e.g. USA, EMEA, Canada, Japan, Brazil, etc. is preferred
• Strong foundation and knowledge in investigative root cause analysis tools such as fishbone analysis, 5 whys
• 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
• Able to communicate and present (both written and oral) across cross function teams of increasing levels of experience and responsibility

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 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:
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Senior/Expert, QA support function

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