Job Description

365 days a year, our global manufacturing and supply network works to ensure our patients have the treatments they need to live longer, healthier lives.

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 objectives.

Key Responsibilities
Your responsibilities include, but are not limited to:

• Provide Quality oversight to site operations/objectives.
• Lead/support in ensuring a smooth manufacturing operation, in handling deviations/CAPA, change control, complaints, customer management, escalation, recall etc. are in full cGMP compliance to regulatory and Novartis Quality Standards
• Own and accountable for end-to-end lifecycle management, timely reviews & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility
• Perform and be responsible in ensuring batch release (manufactured materials \xe2\x80\x93 for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards
• Lead/support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, Process Validation, Ongoing Process Verification & etc.

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

• University degree with a scientific / technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• 8-10 Years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits or new product launches/tech transfer
• Several years of experience in pharmaceutical quality control, quality assurance or production
• GMP experience will be an added advantage
• Strong organizational and time management skills
• Quality oriented with attention to details
• Highly proactive, self-motivated, professional and dedicated

Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

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: https://talentnetwork.novartis.com/network
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

Shift system