Expert – QA Operations

  • Job Category
    Healthcare / Pharmaceutical
  • Job level
  • Contract type
  • Location
  • Salary
    S$8283 - S$9500

Job Description

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?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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:

Closing on 25 Mar 2021