QC Senior Specialist I

Novartis; Southwest; On-site; SGD 45,000 - 85,000; Full time

Job summary

Join a forward-thinking company dedicated to transforming lives through innovative medicines. As a laboratory professional, you will play a crucial role in ensuring quality control and compliance within a dynamic environment. Your expertise in analytical testing and microbiological QC will be vital in supporting product integrity and regulatory standards. This is an exciting opportunity to contribute to groundbreaking advancements in healthcare while collaborating with passionate professionals. If you are ready to make a significant impact in the pharmaceutical industry, this role is perfect for you.

Benefits

Health Insurance

Professional Development Opportunities

Flexible Working Hours

Employee Assistance Program

Wellness Programs

Qualifications

• 3-5 years in analytical lab within pharma/manufacturing sector.
• Experience in GMP environments and collaboration across teams.

Responsibilities

• Handle OOx/Deviation reports and ensure compliance with cGxP.
• Conduct stability testing and prepare reports for supplier qualification.

Skills

Analytical Release Testing

GMP Compliance

Microbiological QC

Data Integrity Review

Trend Analysis

CAPA Definition

Education

Bachelor's Degree in Life Sciences

Certification in Quality Control

Tools

Laboratory Equipment Calibration

Analytical Testing Software

Job description

Summary

• Highly skilled and experienced laboratory professional contributing through analytical release testing, investigational support, research support, and stability testing.

About the Role

Major accountabilities:

• Handling OOx/Deviation reports.
• Defining CAPA, KPI trending, ensuring compliance with cGxP, data integrity review, and approval of analytical data/tests (analytical release).
• Conducting stability testing, including protocol preparation, evaluation, and report writing.
• Reporting activities such as stability plan preparation, trend analysis, and evaluation.
• Performing stability studies, creating protocols, and generating comparative reports for supplier qualification.
• Reviewing and approving analytical tests for release.
• Performing microbiological QC, including testing of materials, utilities, environmental, and personnel monitoring.
• Providing expert support for site qualification and validation activities.
• Maintaining and calibrating equipment, including planning.
• Supporting supplier qualification processes.
• Trending and analyzing KPIs/KQIs.
• Supporting sample planning and sampling execution.
• Reporting technical complaints, adverse events, or special cases related to Novartis products within 24 hours.
• Distributing marketing samples where applicable.

Key performance indicators:

• KPIs in the Quality Control area, such as analytical lead times and GMP compliance.
• Error rates, including the number of OOS (out-of-spec) analysis errors.
• Performance evaluation through PMP performance dialogs.

Minimum Requirements:

• 3-5 years of experience in the pharma/manufacturing sector in an analytical lab.
• Experience working in a GMP environment or equivalent.
• Ability to collaborate across boundaries.

Why Novartis: Helping people with disease and their families requires more than science; it requires a community of passionate, smart individuals working together to achieve breakthroughs that change lives. Join us to create a brighter future: https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right role? Sign up to our talent community to stay connected and learn about future opportunities: https://talentnetwork.novartis.com/network

Benefits and Rewards: Learn about how we support your growth: https://www.novartis.com/careers/benefits-rewards

Division: Operations

Business Unit: Innovative Medicines

Location: Singapore, Tuas South Avenue

Company: Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area: Quality

Job Type: Full-time

Employment Type: Regular

Shift Work: No

Novartis is committed to an inclusive, diverse work environment that reflects the communities we serve.