Summary
This role will ensure proper maintenance of QC IPC/DS (In Process control/Drug Substance) lab equipment and systems and troubleshoot to ensure full cGMP-compliance for shift team.
About the Role
Position Title : QC Analyst II
Location - Singapore #LI Hybrid
About the Role:
This role will ensure proper maintenance of QC IPC/DS (In Process control/Drug Substance) lab equipment and systems and troubleshoot to ensure full cGMP-compliance for shift team.
Key Responsibilities:
• Perform product testing and analysis under cGMP to meet required timelines.
• Provide technical support to run and validate necessary test methods on lab equipment and in developing method transfer/validation protocols and reports.
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• Support lab equipment qualification and improvement projects
• Participate in carrying out laboratory investigations by identifying documents and information to support root causes.
• Prepares and/or review QC documents, including complex assays, to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
• Prepare and participate in health authorities inspections and internal audits in respective area.
• Provide on the job guidance to new job holders to carry out basic day to day lab operation works.
• Suggest ideas and execute improvements to optimize test procedures or efficiency whenever possible.
• Able to support rotating shift hours (Day/night).
Commitment to Diversity & Inclusion: :
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Role Requirements :
Essential Requirements:
• Delivery of results in time and quality (e.g. review and approve validation, qualification protocols and reports)
• Adherence to established KPI targets related to QC activities (global and local)
• Project progressing according to plan and quality expectations.
• Number and severity of cGMP issues identified during internal and external audits
• No critical observations during authority inspections
• No delay with new product introductions caused by the lab
Desirable Requirements:
• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division
Operations
Business Unit
Pharmaceuticals
Location
Singapore
Site
Tuas South Avenue
Company / Legal Entity
SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No