Expert - Quality System, Regulatory & Compliance - Singapore - Novartis

Novartis
Novartis
Verified Company
Singapore

1 week ago

Wei Jie

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Wei Jie

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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

  • Establish and maintain quality management systems at site such as deviations, change control, supplier qualification, audit and inspections management to support the business processes on site in full compliance with applicable regulations and Novartis internal requirements
  • Review and approve change controls, deviation, c reports in compliance with Novartis and applicable cGMP quality standards
  • Establish internal audit plans and execute such plans and followups thus meeting all Novartis internal as well as regulatory requirements to ensure compliance to quality systems
  • Host and manage Health Authority inspections on site (USFDA, EMA, HSA-Singapore)
  • Conduct periodic site quality reviews through platforms such as monthly site quality council to assess the effectiveness of quality management system, identify opportunities for continuous improvement to make sure product manufactured at site meets the required quality standards to assure safety of patients
  • This role is to ensure quality compliance involving inspection management (for both internal and external products)
  • This role is to enable successfully licensure of product manufacturing (for both internal and external products)

Commitment to Diversity & Inclusion:


  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

  • Bachelor's degree in science and related work experience in Pharmaceutical GMP manufacturing environment. Diploma holders can be considered with additional years of work experience
  • More than 8 years of relevant experience in pharmaceutical quality control, quality assurance or production
  • Knowledge of IT Applications & tools Knowledge of Core work processes, Quality Standards, Quality Assurance

Why consider Novartis?

766 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

Division

  • Novartis Technical Operations

Business Unit

  • QUALITY

Country

  • Singapore

Work Location

  • Singapore

Company/Legal Entity

  • NOV SINGAPORE PHARMA MANUFG

Functional Area

  • Quality

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Early Talent

  • No
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