Expert / Senior Specialist QA Ops

325077BR
Oct 01, 2021
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 team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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Novartis Technical Operations
NTO QUALITY
Singapore
Singapore
Quality
Full Time
Regular
No
325077BR

Expert / Senior Specialist QA Ops

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