1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in Generics and Biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

As a QA Lead, you will be involved in assuring that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure \xe2\x80\x9cstate of the art\xe2\x80\x9d GxP know-how and future trends in the field of GxP

Key Responsibilities

• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs
• Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly
• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
• Escalate any issues or instances of instability per the Novartis escalation policy and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and pharmaceutical authorities in respect to up-dated GxP provide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs
• Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.
• Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of pharmaceutical products. Support launches of product in close collaboration with BD& L partner and/ or development organization.
• Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations and ensure that coordinated contact is maintained with all part

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
What you\xe2\x80\x99ll bring to the role:

• Bachelor\'s degree with more than 5 years of relevant experience in quality assurance
• Strong understanding of regulatory requirements for commercial products
• Experience in QMS and SAP will be an added advantage
• Strong Technical understanding of pharmaceutical processes
• Team and consensus builder, with definitive and authoritative decision-making ability

#ORBIT

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\xe2\x80\x99re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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\xe2\x80\x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Join our Novartis Group 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: https://talentnetwork.novartis.com/network
Division
Novartis Technical Operations
Business Unit
QUALITY
Country
Singapore
Work Location
Singapore
Company/Legal Entity
NOV SINGAPORE
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No

Shift system