Expert - QA Operations

Jan 16, 2022

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 support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full GMP compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.

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.
• Participate/Support network governance meeting (as required) and team tiered process to supervise/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 support in ensuring a smooth manufacturing operations, in handling deviations/capa, change control, complaints, customer management, critical issue, 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 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.

Minimum Requirements

• BSc or MSc and related work experience in Pharmaceutical GMP manufacturing (Biotech preferred). Diploma holders can be considered with additional years of work experience.
• 8-10 Years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits or new product launches/tech transfer.
• Good communication skill in English

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!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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:
Novartis Technical Operations
Full Time
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Expert - QA Operations

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